- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767401
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
March 17, 2019 updated by: The First Affiliated Hospital of Dalian Medical University
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: PCI using stenting or balloon expansion
Opening single CTO lesions using drug-eluting stents (such as Xience V and Prime, Endeavor Resolute, Taxus express and Libete, Excel, Partner, BUMA, YINYI, TIVOLI,Firebird2,FireHawk, and Coroflex) or balloon expansion plus optimal medical therapy.
Intravascular ultrasound (IVUS),optimal coherence tomgraphy (OCT) or fractional flow reserve (FFR) is used if they are needed.
Optimal medical therapy includes dual antiplatelet therapy and statins.
And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e.
Beta-blocker or rate-limiting calcium antagonist) where appropriate.
Anti-angina therapy should be used if the patients have symptoms.
|
all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
Other Names:
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.
|
NO_INTERVENTION: Optimal medical therapy
Optimal medical therapy.
It includes dual antiplatelet therapy and statins.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes to myocardial viability
Time Frame: 12 months
|
Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events
Time Frame: 12 months
|
including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization
|
12 months
|
The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
Time Frame: 12 months
|
12 months
|
|
Changes to left ventricular ejection fraction (LVEF)
Time Frame: 12 months
|
Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
|
12 months
|
Changes to myocardial infarct size
Time Frame: 12 months
|
Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.
|
12 months
|
Changes to left ventricular mass (LVM)
Time Frame: 12 months
|
Changes to LVM in g assessed with the use of cardiac MRI.
|
12 months
|
Changes to cardiac output (CO)
Time Frame: 12 months
|
Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
|
12 months
|
Changes to stroke volume (SV)
Time Frame: 12 months
|
Changes to SV in ml assessed with the use of cardiac MRI.
|
12 months
|
Changes to maximum left ventricular ejection rate
Time Frame: 12 months
|
Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
|
12 months
|
Changes to maximum left ventricular filling rate
Time Frame: 12 months
|
Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
|
12 months
|
Changes to maximum slope
Time Frame: 12 months
|
Changes to maximum slope assessed with the use of cardiac MRI.
|
12 months
|
Changes to left ventricular end-diastolic diameter (LVEDd)
Time Frame: 12 months
|
Changes to LVEDd in mm assessed with the use of TTE.
|
12 months
|
Changes to left ventricular end-systolic diameter (LVESd)
Time Frame: 12 months
|
Changes to LVESd in mm assessed with the use of TTE.
|
12 months
|
Changes to cardiac systolic function
Time Frame: 12 months
|
Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke incidence
Time Frame: 12 months
|
12 months
|
|
The number of compliant patients
Time Frame: 12 months
|
Compliant patients are usually defined as those who take predefined percentage (100%) of the treatment
|
12 months
|
The total cost of medical care
Time Frame: 12 months
|
The total cost of medical care include equipment and medication in dollars.
|
12 months
|
Number of guidewires
Time Frame: 12 months
|
Number of guidewires used in the procedure
|
12 months
|
Number of balloons
Time Frame: 12 months
|
Number of balloons used in the procedure
|
12 months
|
Number of stents
Time Frame: 12 months
|
Number of stents used in the procedure
|
12 months
|
the volume of contrast
Time Frame: 12 months
|
the volume of contrast in ml during the procedure
|
12 months
|
type of device
Time Frame: 12 months
|
type of the first guidewire and the final guidewire to cross the proximal lesion such as shaping ribbon or core-to-tip, coil or polymer Cover, hydrophilic coating or hydrophobic coating, and the new devices including Guidezilla™, CrossBoss™ , Tornus, Transporter and Stingray™, any other newest device which will be used before this study is completed.
|
12 months
|
the composite number of special techniques used in the procedure
Time Frame: 12 months
|
the special techniques including parallel wire, see-saw technique, side branch technique, STAR (subintimal tracking and reentry), intravascular ultrasound guiding wire, reverse-controlled antegrade and retrograde subintimal tracking (CART) technique and reverse CART technique.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 15, 2015
Primary Completion (ACTUAL)
August 15, 2018
Study Completion (ACTUAL)
December 15, 2018
Study Registration Dates
First Submitted
October 18, 2015
First Submitted That Met QC Criteria
May 9, 2016
First Posted (ESTIMATE)
May 10, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2019
Last Update Submitted That Met QC Criteria
March 17, 2019
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Myocardial Stunning
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Aspirin
- Ticagrelor
- Atorvastatin
- Clopidogrel
- Rosuvastatin Calcium
- Metoprolol
Other Study ID Numbers
- LCKY2015-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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