The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion

January 10, 2019 updated by: Shanghai Zhongshan Hospital
Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction) grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered in patients undergoing coronary angiography. The application of contemporary techniques and the use of advanced dedicated equipment lead to high procedural success and low adverse events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to assess physiological severity of coronary artery disease and have a prognostic role after percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography) is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to a number of anatomical and pathophysiological changes to the coronary circulation. These include anatomical and functional collateral vessels regression and significant lumen enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term follow-up.

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 (Anticipated)

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.
150

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan 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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients of single coronary chronic total occlusion

Description

Inclusion Criteria:

  • age >18 years old
  • single CTO lesions, or other stenosis have been PCI treated for more than one months
  • the diameter of target vessel ≥2.5mm
  • stable angina pectoris, or myocardial ischemia in the area of CTO lesions
  • the patients agree to this research plan and sign the consent form, and complete the follow-up

Exclusion Criteria:

  • Acute myocardial infarction in one month
  • In addition to the area of CTO lesions, there are serious untreated coronary lesions
  • bridge vascular CTO lesions
  • untreated coronary artery or cardiac surgery due to interventional complications, or intraoperative death
  • acute decompensated heart failure
  • allergies to contrast or radionuclide tracers
  • patients with planned pregnancies or lactation or 1 years after intervention
  • malignant neoplasms or life expectancy of less than 1 years
  • patients plan of surgery
  • patients cannot tolerate double antiplatelet therapy for at least 12 months
  • any condition that does not fit coronary intervention or is a drug-eluting stent

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
single coronary chronic total occlusion

symptomatic stable angina of single coronary chronic total occlusion without other coronary artery stenosis scheduled for elective PCI.

fractional flow reserve and SPECT detection before and after intervention.
Other: fractional flow reserve and SPECT detection
fractional flow reserve and SPECT detection

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
score of Seattle angina questionnaire
Time Frame: one year
the result of Seattle angina questionnaire
one year
socre of Self-Rating Anxiety Scale
Time Frame: one year
result of socre of Self-Rating Anxiety Scale
one year
socre of EuroQol five dimensions questionnaire
Time Frame: one year
result of EuroQol five dimensions questionnaire
one year
Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
Time Frame: one year
Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
one year
the success rate of Percutaneous Coronary Intervention
Time Frame: one year
the success rate of Percutaneous Coronary Intervention
one year

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
rate of cardiac death rate
Time Frame: one year
rate of cardiac death rate in one year recorded in follow-up
one year
rate of target vessel revascularization rate
Time Frame: one year
rate of target vessel revascularization rate in one year recorded in follow-up
one year
rate of recurrent myocardial infarction rate
Time Frame: one year
rate of recurrent myocardial infarction rate in one year recorded in follow-up
one year

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.
Shanghai Zhongshan Hospital

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.
  • Principal Investigator: Jianying Ma, Doctor, Department of Cardiology, Zhongshan 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 (Anticipated)

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.
January 1, 2019

Primary Completion (Anticipated)

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.
December 1, 2021

Study Completion (Anticipated)

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.
December 1, 2021

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).
December 28, 2018

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.
January 10, 2019

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.
January 14, 2019

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.
January 14, 2019

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.
January 10, 2019

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.
January 1, 2019

More Information

Terms related to this study

Keywords

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.
  • SHDC12018X05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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