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

Study Overview
=================
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.

Official Title
-----------------
The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study

Conditions
-----------------
Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention, Viable Myocardium

Intervention / Treatment
-----------------
* Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
* Device: coronary wires. stents or coronary balloons


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complete revascularization group<br>Complete Revascularization of CTO and non-CTO lesions | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor<br>* 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.<br>* Other names: Optimal medical therapy;Device: coronary wires. stents or coronary balloons<br>* all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)<br>* Other names: percutaneous coronary intervention;|
| Non-CTO revascularization group<br>Non-CTO vessel revascularization | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor<br>* 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.<br>* Other names: Optimal medical therapy;Device: coronary wires. stents or coronary balloons<br>* all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)<br>* Other names: percutaneous coronary intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of left ventricular ejection fraction (LVEF) | Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events | 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 | 1, 6, and 12 months post-PCI | 
| Myocardial viability | myocardial viability in the territory supplied by the CTO artery | 12 months post-PCI | 
| Quality of life changes | Seattle Angina Questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 | 1, 6, and 12-month follow-up | 
| Contrast used | contrast used | during the procedure | 
| Total cost of medical care | 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) | from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic total coronary artery occlusion, multi-vessel coronary artery disease, Percutaneous coronary intervention, coronary artery disease, cardiac function