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The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)

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ClinicalTrials.gov Identifier: NCT02767401
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Beijing Anzhen Hospital
First Hospital of China Medical University
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
The First Affiliated Hospital of Dalian Medical University

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.

Condition or disease Intervention/treatment Phase
Hibernation, Myocardial Complete Occlusion of Coronary Artery Device: stenting or balloon expansion Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : December 15, 2018

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.
Device: stenting or balloon expansion
all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
Other Name: percutaneous coronary intervention

Drug: aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. The rates of target vascular revascularization (TVR), TLR, and stent thrombosis [ Time Frame: 12 months ]
  3. 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).

  4. 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.

  5. Changes to left ventricular mass (LVM) [ Time Frame: 12 months ]
    Changes to LVM in g assessed with the use of cardiac MRI.

  6. 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.

  7. Changes to stroke volume (SV) [ Time Frame: 12 months ]
    Changes to SV in ml assessed with the use of cardiac MRI.

  8. 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.

  9. 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.

  10. Changes to maximum slope [ Time Frame: 12 months ]
    Changes to maximum slope assessed with the use of cardiac MRI.

  11. Changes to left ventricular end-diastolic diameter (LVEDd) [ Time Frame: 12 months ]
    Changes to LVEDd in mm assessed with the use of TTE.

  12. Changes to left ventricular end-systolic diameter (LVESd) [ Time Frame: 12 months ]
    Changes to LVESd in mm assessed with the use of TTE.

  13. 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.


Other Outcome Measures:
  1. Stroke incidence [ Time Frame: 12 months ]
  2. The number of compliant patients [ Time Frame: 12 months ]
    Compliant patients are usually defined as those who take predefined percentage (100%) of the treatment

  3. The total cost of medical care [ Time Frame: 12 months ]
    The total cost of medical care include equipment and medication in dollars.

  4. Number of guidewires [ Time Frame: 12 months ]
    Number of guidewires used in the procedure

  5. Number of balloons [ Time Frame: 12 months ]
    Number of balloons used in the procedure

  6. Number of stents [ Time Frame: 12 months ]
    Number of stents used in the procedure

  7. the volume of contrast [ Time Frame: 12 months ]
    the volume of contrast in ml during the procedure

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767401


Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Beijing Anzhen Hospital
First Hospital of China Medical University
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Rongchong Huang, M.D. The First Affiliated Hospital of Dalian Medical University
Publications:
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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT02767401    
Other Study ID Numbers: LCKY2015-22
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2018
Keywords provided by The First Affiliated Hospital of Dalian Medical University:
PET-CT
Cardiac magnetic resonance (CMR) imaging
Major adverse cardiac events (MACEs)
coronary artery disease
Additional relevant MeSH terms:
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Myocardial Stunning
Heart Diseases
Cardiovascular Diseases
Aspirin
Metoprolol
Clopidogrel
Ticagrelor
Atorvastatin
Rosuvastatin Calcium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Purinergic P2Y Receptor Antagonists