Chronic Total Occlusive Lesions CMR Study

NCT ID: NCT05614180

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2025-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Total Occlusion Image Revascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous coronary intervention

Patients with a diagnose of coronary chronic total occlusions will be treated by percutaneous coronary intervention, as indicated by the heart-team.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lin Zhao

OTHER

Sponsor Role lead

Responsible Party

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Lin Zhao

Associate director of cardiology department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lin Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

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Beijing anzhen hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xu Wang, MD

Role: CONTACT

+8615311765609

Facility Contacts

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Xu Wang

Role: primary

+86 15311765609

Other Identifiers

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KS2022056

Identifier Type: -

Identifier Source: org_study_id

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