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Chronic Total Occlusive Lesions CMR Study

Chronic Total Occlusive Lesions CMR Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05614180
Acronym
CTO-CMR
Enrollment
400
Registered
2022-11-14
Start date
2023-01-20
Completion date
2025-12-01
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion, Image, Revascularization

Keywords

Chronic Total Occlusion, Cardiac magnetic resonance, Revascularization

Brief summary

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).

Interventions

PROCEDUREPercutaneous coronary intervention

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

Sponsors

Lin Zhao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in ischemia3 months; 12 monthsParameters of cardiac magnetic resonance

Secondary

MeasureTime frameDescription
Rate of target lesion failure (TLF).12 monthsTLF is defined as a composite of: cardiac death, target vessel myocardial infarction (SCAI definition), and clinically driven TLR.
Changes in angina paramteres3 months; 12 monthsParameters of angina questionnaires.
Change of left ventricular structure and function3 months; 12 monthsParameters of left ventricular function and structure on cardiac magnetic resonance

Countries

China

Contacts

Primary ContactXu Wang, MD
huaianwangxu@126.com+8615311765609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026