Chronic Total Occlusive Lesions CMR Study (CTO-CMR)

July 28, 2023 updated by: Lin Zhao
This registry will include consecutive patients presenting with at least one chronic total occlusion on coronary angiogram who will be treated by percutaneous coronary intervention in our center. All patients will undergo a non-invasive assessment for myocardial ischemia/viability using cardiac magnetic resonance (CMR) prior to revascularization therapy. Follow up CMR will be repeated in all participants after three months and one year. Additionally, clinical outcomes and quality of life will be evaluated at baseline and at follow-up. Primary objective of this study is to investigate the the reduction in ischemia (as evaluated by follow-up CMR) and the severity of angina according to clinical evaluation (including Seattle Angina Questionnaires [SAQ], Canadian Class Score[CCS] and 6-mins walking test).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes patients presenting with a diagnose of coronary chronic total occlusions undergoing percutaneous coronary intervention.

Description

Inclusion Criteria:

  • Age > 18 years
  • Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
  • Patient has a clinical indication to perform CTO PCI
  • Willing to participate and able to understand, read and sign the informed consent document.

Exclusion Criteria:

  • CMR contraindications
  • Contraindications to adenosine or dobutamine
  • Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] <60 mL/min/1.73m2 or serum creatinine level >2.5 mg/dL)

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ischemia
Time Frame: 3 months; 12 months
Parameters of cardiac magnetic resonance
3 months; 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of target lesion failure (TLF).
Time Frame: 12 months
TLF is defined as a composite of: cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven TLR.
12 months
Changes in angina paramteres
Time Frame: 3 months; 12 months
Parameters of angina questionnaires.
3 months; 12 months
Change of left ventricular structure and function
Time Frame: 3 months; 12 months
Parameters of left ventricular function and structure on cardiac magnetic resonance
3 months; 12 months

Collaborators and Investigators

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

Sponsor

Lin Zhao

Investigators

  • Principal Investigator: Lin Zhao, MD, Beijing Anzhen 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)

January 20, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 5, 2022

First Submitted That Met QC Criteria

November 5, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KS2022056

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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