Chronic Total Occlusive Lesions CMR Study

NCT05614180 | Unknown DMC

• 1 other identifier: KS2022056
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Total Occlusion; Image; Revascularization

Keywords

Chronic Total Occlusion; Cardiac magnetic resonance; Revascularization

Outcome Measures

Primary Outcomes (1)

• Change in ischemia

  Parameters of cardiac magnetic resonance

  3 months; 12 months

Secondary Outcomes (3)

• Rate of target lesion failure (TLF).

  12 months

• Changes in angina paramteres

  3 months; 12 months

• Change of left ventricular structure and function

  3 months; 12 months

Interventions

Percutaneous coronary intervention PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lin Zhao: lead

Study Sites (1)

Beijing anzhen hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Lin Zhao, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Wang, MD

CONTACT

+8615311765609; huaianwangxu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate director of cardiology department

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: January 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)