Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy (SLEEP)

February 4, 2022 updated by: University of Aarhus

Background:

Diabetes, and especially diabetic kidney disease is associated with the development of cardiovascular disease such as calcification in the coronary arteries and heart failure. Sleep apnea is frequent among patients with diabetes and diabetic kidney disease and sleep apnea itself is a solitary risk factor in the development of cardiovascular disease. Nonetheless, sleep apnea is underdiagnosed in diabetes patients because of a discrepancy between sleep apnea severity and actual oxygen deficiency symptoms which makes the diagnosis difficult. For that reason, many diabetics have undiagnosed sleep apnea together with cardiovascular disease. Early discovery of sleep apnea among high risk diabetic patients may therefore be considered crucial before cardiovascular complications develop. For this reason, sleep apnea screening of high-risk diabetics can possibly improve early diagnostics of cardiovascular disease.

Aim:

This study will seek to establish the association between obstructive sleep apnea (OSA) and coronary calcification and heart failure in patients with diabetic kidney disease. The basic hypothesis of the study is that patients with diabetic kidney disease and concurrent OSA have a higher prevalence and severity of coronary calcification and heart failure compared to patients without OSA.

Methods:

Diabetic adult patients with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital will be included in the study.

Firstly, all included patients are screened for sleep apnea with the devices SomnoTouch® and ApneaLink®. Based on the sleep apnea determination; 40 patients with moderate-severe sleep apnea are compared with 40 patients without sleep apnea. In both groups, the patients are examined for calcification in the coronary vessels using a CT-scan while the function of the heart is examined by ultrasound (echocardiography). The stiffness of aorta is measured and performed using radial artery tonometry (SphygmoCor®).

Furthermore, range of blood- and urine samples will be performed

The perspectives are that patients with diabetes should be regularly evaluated for sleep apnea and that patients with moderate/severe sleep apnea should undergo further examination for cardiovascular disease even though the patients don't display any symptoms of either cardiovascular disease or sleep apnea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic adult patients (Type 2) with scheduled check-ups at Steno Diabetes Center Aarhus, or Department of Renal Medicine on Aarhus University Hospital can be included in the study if they satisfy all eligible criteria. Additionally, patients from the GP and within the including area of Aarhus University Hospital were invited to participate in the study.

The study cohort will consist of:

Generel characteristics of both groups:

- Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m^2

Sleep Apnea:

  1. 40 patients with an apnea/hyponea-index above ≥ 15 per hour.

    Non-Sleep Apnea:

  2. 40 patients with an apnea/hyponea-index below < 5 per hour.

Description

Inclusion Criteria:

  • ≥ 18 years.
  • Diabetes Mellitus Type 2 with an eGFR between 10-60 ml/min/1,73 m^2 (Equalling CKD-group 3, 4 and 5 non-dialysis).

Exclusion Criteria:

  • Known sleep apnea in continuous positive airway pressure(CPAP) treatment.
  • Known mild sleep apnea (AHI 5-14) after the sleep apnea measurement.
  • Participants with central apnea (> 50 % of central apnea episodes in the AHI ≥ 15 group.) or Cheyne Stokes after the sleep apnea measurement.
  • < 4 hours of recording (ApneaLink)
  • Known coronary arterial disease with previous revascularization (PCI or CABG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Sleep Apnea (AHI ≥ 15 per hour)
Patients with moderate/severe sleep apnea (Apnea/hypopnea-index ≥ 15 per hour).
Non-Sleep Apnea (AHI < 5 per hour)
Patients without sleep apnea (Apnea/hypopnea-index < 5 per hour).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The association between sleep apnea and coronary atherosclerosis (Agatston Score) measured with cardiac CT-scan in patients with diabetic nephropathy.
Time Frame: Cardiac CT-scan will be performed no later than 1 month after inclusion. All Agatston scores will be estimated straight after the cardiac CT-scan.

The degree of atherosclerosis in the coronary artery walls is evaluated by cardiac CT-scan and subsequent quantified by Agatston score. Patients with an estimated glomerular filtration rate (eGFR) ≤ 25 ml/min/1,73 m2 is scanned without contrast whereas patients with an eGFR 26-60 ml/min/1,73 m2 are screened with contrast.

All Agatston scoring will be performed by a cardiologist blinded to information on patient biochemical characteristics and AHI. The only biochemical parameter which the cardiologist is not blinded to is eGFR.
Cardiac CT-scan will be performed no later than 1 month after inclusion. All Agatston scores will be estimated straight after the cardiac CT-scan.
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by two-dimensional automated evaluation of ejection fraction (2-D auto-EF).

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
The association between sleep apnea and diastolic heart failure in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in the study will undergo transthoracic echocardiography. Diastolic function is evaluated by E/e´.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
The association between sleep apnea and systolic function in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in the study will undergo transthoracic echocardiography. Systolic function is evaluated by Left Ventricular Global Longitudinal Strain (GLS).

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The association between sleep apnea and coronary plaque volume in patients with diabetic nephropathy.
Time Frame: Cardiac CT-scan will be performed no later than 1 month after inclusion.

Coronary plaque volume is estimated by a cardiac CT-scan with contrast.

All coronary plaque volume analysing will be performed by a cardiologist blinded to information on patient biochemical characteristics and AHI. The only biochemical parameter which the cardiologist is not blinded to is eGFR.
Cardiac CT-scan will be performed no later than 1 month after inclusion.
Association of sleep apnea and aortic stiffness (defined as Pulse Wave Velocity (PWV)) in patients with diabetic nephropathy.
Time Frame: PWV is performed the same day as the patient is included.
To get a non-invasive estimate of the aortic stiffness, measurement of Pulse Wave Velocity (PWV) (carotid-femoral and carotid-radial) will be performed. PWV will be recorded with the Sphygmocor® device according to regular protocol. If possible, two acceptable measurements will be conducted for each included patient. Calculation of PWV will be performed automatically by the device using a previously published formula.
PWV is performed the same day as the patient is included.
Association between Matrix Gla Protein (MGP) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. MGP, a novel biochemical marker of arterial calcification, will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Calcification propensity score (T50test) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. Calcification propensity score (T50test) will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. sRANKL (soluble receptor activator of nuclear factor kappa-B ligand) will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between 25-OH-Vitamin D(D3+D2) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. 25-OH-Vitamin D(D3+D2) will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy. Fetuin-A(alfa-2-Heremans Schmid glycoprotein; AHSG) will be collected and analysed in all patients
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021.
Association between Sclerostin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., Sclerostin will be collected and analysed in all patients
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between osteoprotegerin and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., osteoprotegerin will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between BsAP (bone-specific alkaline phosphatase) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., BsAP (bone-specific alkaline phosphatase) will be collected and analysed in all patients
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between TRAP5B (tartrate-resistant acid phosphatase 5b) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy, TRAP5B (tartrate-resistant acid phosphatase 5b) will be collected and analysed in all patients.
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between P1NP (procollagen type 1 N propeptide) and coronary calcification in patients with sleep apnea and diabetic nephropathy.
Time Frame: Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
To establish a deeper understanding of the pathogenesis of central arterial calcification in patients with sleep apnea and diabetic nephropathy., P1NP (procollagen type 1 N propeptide) will be collected and analysed in all patients
Analysis will be performed as batch-analysis at the end of inclusion of patients summer 2021
Association between LVEDd (Left ventricular end diastolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between LVEDs (Left ventricular end systolic diameter) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSd (Interventricular Septal Thickness at Diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between IVSs (Interventricular Septal Thickness at Systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTd (Posterior wall thickness at end-diastole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between PWTs (Posterior wall thickness at end-systole) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (sinus valsalva) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Ascendens) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Aorta (Abdominalis) diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between maximum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between minimum Vena Cava Inferior diameter as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Early mitral inflow velocity (E) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Late mitral inflow velocity (A) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between E/A-ratio as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Deceleration time of early diastolic transmittal flow (dtE) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between Right ventricular diameter (RVD) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus.

The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between left atrial volume (LAV) as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
Association between 2D atrial global strain as determined during echocardiography and sleep apnea in patients with diabetic nephropathy.
Time Frame: Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan
All patients included in this study will undergo echocardiography. In particular systolic and diastolic function will be in focus. The echocardiographic-clinician is blinded to AHI-status.
Transthoracic echocardiography will be performed no later than 1 month after inclusion and prior to cardiac CT-scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Niels H. Buus, MD PhD DMSc, Department of Renal diseases, Aarhus University Hospital
  • Principal Investigator: Sebastian Nielsen, MD student, Department of Renal diseases, Aarhus University Hospital
  • Study Chair: Jakob T. Nyvad, MD, The Clinic of Hypertension, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-122-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD. pas

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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