Clinical trial NCT03372785: The Success of Opening Concurrent CTO leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Total Occlusion of Coronary Artery
Percutaneous Coronary Intervention
Coronary Artery Disease
Viable Myocardium
Keywords: Chronic total coronary artery occlusion
multi-vessel coronary artery disease
Percutaneous coronary intervention
coronary artery disease
cardiac function
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Dalian Medical University
name: Beijing Friendship Hospital
First posted: 2017-12-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

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.

Primary outcomes:
measure: Changes of left ventricular ejection fraction (LVEF)
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 1, 6, and 12 months post-PCI
measure: Myocardial viability
timeFrame: 12 months post-PCI
measure: Quality of life changes
timeFrame: 1, 6, and 12-month follow-up
measure: Contrast used
timeFrame: during the procedure
measure: Total cost of medical care
timeFrame: from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization)
Other outcomes:
measure: Safety endpoints
timeFrame: perioperative period
Locations:
city: Beijing
country: China
facility: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiantao Song, MD
role: PRINCIPAL_INVESTIGATOR
References: