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

Coronary Artery Disease Clinical Trial

— SOS-moral  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03372785
• Other study ID #: SOS-moral
• Status: Enrolling by invitation
• Start date: April 10, 2018
• Est. completion date: April 2022

Study information

• Verified date: August 2020
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Viable Myocardium

Intervention

Drug:
• 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.

Device:
• coronary wires. stents or coronary balloons
all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)

Locations

Country	Name	City	State
China	Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Friendship Hospital, The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints	The safety of the perioperative period, including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death	perioperative period
Primary	Changes of left ventricular ejection fraction (LVEF)	Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI.	12 months
Secondary	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
Secondary	Myocardial viability	myocardial viability in the territory supplied by the CTO artery	12 months post-PCI
Secondary	Quality of life changes	Seattle Angina Questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7	1, 6, and 12-month follow-up
Secondary	Contrast used	contrast used	during the procedure
Secondary	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)