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

NCT ID: NCT03372785

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2022-04-30

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.

Conditions

Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Coronary Artery Disease; Viable Myocardium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Complete revascularization group

Complete Revascularization of CTO and non-CTO lesions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Intervention Type: DRUG

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

coronary wires. stents or coronary balloons

Intervention Type: DEVICE

all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)

Non-CTO revascularization group

Non-CTO vessel revascularization

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Intervention Type: DRUG

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

coronary wires. stents or coronary balloons

Intervention Type: DEVICE

all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)

Interventions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.

Intervention Type: DRUG

coronary wires. stents or coronary balloons

all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)

Intervention Type: DEVICE

Other Intervention Names

Optimal medical therapy; percutaneous coronary intervention

Eligibility Criteria

Inclusion Criteria

Patients should be 18-80 years old; be diagnosed with single CTO concurrent with MVD detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis); present with an LVEF above 35% determined using transthoracic echocardiography; present with CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm; and comply all the evaluations and follow-up protocols.

Exclusion Criteria

Patients will be excluded if they have suffered from acute myocardial infarction within the previous 3 months; a lesion located in the left main artery (stenosis ≥50%); rheumatic valvular disease; severe arrhythmia; a history of revascularization within the non-CTO artery; multiple vessels with CTO (more than one CTO artery); lesions unsuitable for PCI; severely abnormal hematopoietic systems, such as platelet counts <100 x 109/L or > 700 x 109/L and white blood cell counts < 3 x 109/L; with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency); severe coexisting conditions, including severe renal function dysfunction [Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months; a life expectancy less than 12 months; pregnancy or planning to become pregnant; history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents. Patients will also be excluded if they cannot tolerate dual antiplatelet treatment (DAPT); are unable to communicate due to cognitive impairment, auditory, or visual impairment; are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiantao Song, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiantao Song, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

SOS-moral

Identifier Type: -

Identifier Source: org_study_id