Clinical trial NCT02767401: The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
Official title: The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hibernation, Myocardial
Complete Occlusion of Coronary Artery
Keywords: PET-CT
Cardiac magnetic resonance (CMR) imaging
Major adverse cardiac events (MACEs)
coronary artery disease
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: First Hospital of China Medical University
name: Nanfang Hospital, Southern Medical University
First posted: 2016-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on myocardial viability in coronary artery disease patients with single coronary total occlusion (CTO) lesions.

Detailed description: Patients with coronary artery disease might benefit from successful percutaneous coronary intervention (PCI). However, there is currently no consensus on an optimal treatment modality for single lesions resulting in coronary total occlusion (CTO). Since the other coronary arteries are often lesion-free, or with stenosis of less than 50%, patients often present with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence of long-term adverse events via successful revascularization, there are few retrospective studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal medication treatment (OMT) can increase myocardial viability and the extent of myocardial viability related to prognosis of those CTO patients. Therefore, the aim of this multi-center, prospective, open labeled, non-randomized controlled study was to determine if the improvement to myocardial viability in single CTO patients with successful PCI plus OMT was superior to that of patients with only OMT.

Eligibility criteria: Inclusion Criteria:

* History of stable or unstable angina
* LVEF \> 35% on transthoracic echocardiography measurement
* Single lesion occluding the coronary artery detected by angiography or MSCTA, with or without stenosis of other coronary arteries (≤ 50% stenotic lesion)
* Availability for follow-up for up to 12 months
* No major barriers to provide written consent

Exclusion Criteria:

* Acute Q-wave myocardial infarction during the latest 3 months
* Revascularization in the non-culprit artery during the latest one month
* Unsuitable for PCI
* Unable to tolerate dual antiplatelet treatment (DAPT)
* Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L
* Active bleeding or bleeding tendency
* Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamic-pyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
* Life expectancy \< 12 months
* Pregnancy or planning pregnancy
* Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
* Participation or planning to participate in another clinical trial during the same period
* Refusal to comply with the study protocol

Primary outcomes:
measure: Changes to myocardial viability
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 12 months
measure: The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
timeFrame: 12 months
measure: Changes to left ventricular ejection fraction (LVEF)
timeFrame: 12 months
measure: Changes to myocardial infarct size
timeFrame: 12 months
measure: Changes to left ventricular mass (LVM)
timeFrame: 12 months
measure: Changes to cardiac output (CO)
timeFrame: 12 months
measure: Changes to stroke volume (SV)
timeFrame: 12 months
measure: Changes to maximum left ventricular ejection rate
timeFrame: 12 months
measure: Changes to maximum left ventricular filling rate
timeFrame: 12 months
measure: Changes to maximum slope
timeFrame: 12 months
measure: Changes to left ventricular end-diastolic diameter (LVEDd)
timeFrame: 12 months
measure: Changes to left ventricular end-systolic diameter (LVESd)
timeFrame: 12 months
measure: Changes to cardiac systolic function
timeFrame: 12 months
Other outcomes:
measure: Stroke incidence
timeFrame: 12 months
measure: The number of compliant patients
timeFrame: 12 months
measure: The total cost of medical care
timeFrame: 12 months
measure: Number of guidewires
timeFrame: 12 months
measure: Number of balloons
timeFrame: 12 months
measure: Number of stents
timeFrame: 12 months
measure: the volume of contrast
timeFrame: 12 months
measure: type of device
timeFrame: 12 months
measure: the composite number of special techniques used in the procedure
timeFrame: 12 months
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Rongchong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Namazi M, Safi M, Vakili H, Saadat H, Alipour S, Mahjoob P, Taherkhani M, Pedari S, Taherion M, Rajabi Moghaddam H, Alhazifi A, Vatanparast M, Khaligh S. Evaluation of effective factors in success rate of intervention on CTO. Acta Med Iran. 2015;53(3):173-6.
citation: Stuijfzand WJ, Raijmakers PG, Driessen RS, van Royen N, Nap A, van Rossum AC, Knaapen P. Value of Hybrid Imaging with PET/CT to Guide Percutaneous Revascularization of Chronic Total Coronary Occlusion. Curr Cardiovasc Imaging Rep. 2015;8(7):26. doi: 10.1007/s12410-015-9340-2.
citation: Lee SH, Yang JH, Choi SH, Song YB, Hahn JY, Choi JH, Kim WS, Lee YT, Gwon HC. Long-Term Clinical Outcomes of Medical Therapy for Coronary Chronic Total Occlusions in Elderly Patients (>/=75 Years). Circ J. 2015;79(8):1780-6. doi: 10.1253/circj.CJ-15-0041. Epub 2015 May 28.