The Success of Opening Concurrent CTO leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease

• Conditions: Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Viable Myocardium; Coronary Artery Disease
• Interventions: Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. stents or coronary balloons

• Registration Number: NCT03372785
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total occlusion (CTO) lesion.

Detailed Description

Recruited CTO patients will be devided into two groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome assessed will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.

Study Timeline

• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-10
• Study First Posted: 2017-12-14
• Study Start: 2018-04-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-29
• Last Update Posted: 2020-09-01
• Primary Completion: 2021-12
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complete revascularization group	aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor	Complete Revascularization of CTO and non-CTO lesions
Non-CTO revascularization group	aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor	Non-CTO vessel revascularization
Complete revascularization group	coronary wires. stents or coronary balloons	Complete Revascularization of CTO and non-CTO lesions
Non-CTO revascularization group	coronary wires. stents or coronary balloons	Non-CTO vessel revascularization

Primary Outcome Measures

Name	Time	Method
Changes of left ventricular ejection fraction (LVEF)	12 months	Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI.

Secondary Outcome Measures

Name	Time	Method
Myocardial viability	12 months post-PCI	myocardial viability in the territory supplied by the CTO artery
Quality of life changes	1, 6, and 12-month follow-up	Seattle Angina Questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7
Total cost of medical care	from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization)	total cost of medical care covering optimal medicine therapy and the equipment for coronary artery disease therapy from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization)
Major adverse cardiac events	1, 6, and 12 months post-PCI	all-cause mortality, cardiac death, a first or recurrent, non-fatal, acute myocardial infarction, target lesion revascularization (PCI or CABG), stroke, heart failure and cardiac rehospitalization
Contrast used	during the procedure	contrast used

Trial Locations

Locations (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, China