- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044901
Cardiovascular Complications of Sickle Cell Disease
February 8, 2022 updated by: University of Chicago
In this research study, we are using heart imaging exams and blood testing, in order to gain an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart) complications that often occur in sickle cell patients.
Information gathered from the healthy volunteers that participate in this study will be compared to information from the sickle cell patients in this study in order to help further our understanding.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cardiac magnetic resonance (CMR) has gained increasing clinical application in cardiopulmonary diseases.
Due to its 3-dimensional nature, CMR is considered the gold-standard for quantifying left and right ventricular systolic function and size.
Additionally, its high tissue contrast allows for a detailed characterization of myocardial tissue.
Specifically, the use of techniques such as late gadolinium enhancement can be used to detect the presence of tiny amounts of myocardial scar.
Other techniques have been shown to correlate strongly with myocardial iron content.
Just as importantly, CMR perfusion imaging can accurately quantify myocardial blood flow and can provide tremendous insight into the function of the microcirculation.
CMR's high spatial and temporal resolution, its 3-dimensional approach, its ability to characterize the tissue, and its ability to evaluate the micro- and macro-circulation make it a comprehensive technique for the evaluation of heart disease.
Recently, one CMR study has already shown the presence of cardiac microvascular disease in a subset of adult sickle cell disease (SCD) patients in the absence of infarcted myocardium, myocardial iron overload, or coronary artery disease, increasing the evidence for the contribution of left heart disease to pulmonary hypertension (PH) development in these patients; unfortunately, strong conclusions could not be made because the study was underpowered.
Thus, this proposal will leverage the advantages offered by CMR to better characterize and detect the PH and cardiopulmonary subphenotypes in the SCD patient population.
Study Type
Observational
Enrollment (Actual)
51
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
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Illinois
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Chicago, Illinois, United States, 60430
- University of Chicago Medical Center
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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
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
Subjects will be recruited from clinics at the University of Chicago as well as from the community via flyers posted at the University of Chicago and a web site posted on the University of Chicago Medical Center web site.
Description
Inclusion Criteria:
- Patients must be 18+
- Patients who were diagnosed with SCD confirmed by high-pressure liquid chromatography or hemoglobin electrophoresis will be eligible for the study
- Only patients in stable condition will be included
- Patients receiving transfusions will not be excluded
Exclusion Criteria:
- Patients with vaso-occlusive crises or an episode of acute chest syndrome within the previous four weeks (after 4 weeks have passed, the patients may be re-evaluated for eligibility)
- Patients with high degree heart block; active, hemodynamically significant, ventricular arrhythmias; unstable coronary syndromes; history of myocardial infarction within 1 month of the study.
- Contraindications to gadolinium-enhanced magnetic resonance examination such as severe claustrophobia, Pacemaker, defibrillators, cerebral aneurysm clips, or neurostimulator.
- Pregnancy
- Patients with sinus node dysfunction
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 |
Intervention / Treatment |
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Subjects with Sickle Cell Disease (SCD)
38 clinically stable black patients with Sickle Cell Disease (SCD) (including individuals with hemoglobin SS, SC, and β-thalassemia demonstrated by high-performance liquid chromatographic separation or gel electrophoresis).
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Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance.
The tonometer, EKG, and echo are non-invasive procedures.
Other Names:
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Healthy Volunteers
13 healthy control subjects were frequency matched to patients with SCD on age, sex, and race.
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Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance.
The tonometer, EKG, and echo are non-invasive procedures.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI Parameter - LVEDVi, mL/cm2 (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
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MRI Parameter - LVESVi, mL/cm2 - (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
|
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
|
MRI Parameter - LV Mass Index, g/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
|
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
|
MRI Parameter - RVEDVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
|
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
|
MRI Parameter - RVESVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
|
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - LAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - RAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
|
Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
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MRI Parameter - LVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - RVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)
Time Frame: Parameter at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter at baseline.
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MRI Parameter - Late Gadolinium Enhancement, Performed Via Visual Inspection, Normally None Should be Present
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
|
MRI Parameter - Myocardial T2-star, ms, Performed Using Decay Curves (Normal >20ms)
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Hepatic T2-star, ms, Performed Using Decay Curves, Normal >18ms
Time Frame: Parameter at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter at baseline.
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MRI Parameter - Myocardial Perfusion Reserve Index, Measured Using Upslope Technique. Control Subjects Available for Normal Ranges
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Diastolic Dysfunction, Determined According to American Society of Echocardiography Guidelines
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Lateral E/e', Measured Using Doppler Echo. Controls Available as Normal Ranges
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Augmentation Pressure, See Controls for Normal Ranges
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Augmentation Index, See Control Subjects for Normal Ranges
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Systemic Systolic Blood Pressure
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
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Parameter measured at baseline.
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MRI Parameter - Systemic Diastolic Blood Pressure, mm Hg
Time Frame: Parameter measured at baseline.
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Comprehensively and quantitatively characterized the cardiopulmonary complications of SCD and gained an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease.
|
Parameter measured at baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genome-Wide Gene Expression and Targeted Genetic Polymorphisms in SCD Patients Linked to a Quantitative Noninvasive-based PH Phenotype.
Time Frame: median follow up 3 years
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To detect genome-wide gene expression and targeted genetic polymorphisms in SCD patients linked to a quantitative noninvasive-based PH phenotype.
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median follow up 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amit R Patel, M.D., University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2009
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 7, 2010
First Posted (Estimate)
January 8, 2010
Study Record Updates
Last Update Posted (Actual)
February 23, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16653A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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