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

Primary Purpose

Hibernation, Myocardial, Complete Occlusion of Coronary Artery

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
stenting or balloon expansion
aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hibernation, Myocardial focused on measuring PET-CT, Cardiac magnetic resonance (CMR) imaging, Major adverse cardiac events (MACEs), coronary artery disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    PCI using stenting or balloon expansion

    Optimal medical therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes to myocardial viability
    Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system

    Secondary Outcome Measures

    Major adverse cardiac events
    including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization
    The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
    Changes to left ventricular ejection fraction (LVEF)
    Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
    Changes to myocardial infarct size
    Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.
    Changes to left ventricular mass (LVM)
    Changes to LVM in g assessed with the use of cardiac MRI.
    Changes to cardiac output (CO)
    Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
    Changes to stroke volume (SV)
    Changes to SV in ml assessed with the use of cardiac MRI.
    Changes to maximum left ventricular ejection rate
    Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
    Changes to maximum left ventricular filling rate
    Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
    Changes to maximum slope
    Changes to maximum slope assessed with the use of cardiac MRI.
    Changes to left ventricular end-diastolic diameter (LVEDd)
    Changes to LVEDd in mm assessed with the use of TTE.
    Changes to left ventricular end-systolic diameter (LVESd)
    Changes to LVESd in mm assessed with the use of TTE.
    Changes to cardiac systolic function
    Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.

    Full Information

    First Posted
    October 18, 2015
    Last Updated
    March 17, 2019
    Sponsor
    The First Affiliated Hospital of Dalian Medical University
    Collaborators
    Beijing Anzhen Hospital, First Hospital of China Medical University, Nanfang Hospital, Southern Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767401
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2015 (Actual)
    Primary Completion Date
    August 15, 2018 (Actual)
    Study Completion Date
    December 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Dalian Medical University
    Collaborators
    Beijing Anzhen Hospital, First Hospital of China Medical University, Nanfang Hospital, Southern Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hibernation, Myocardial, Complete Occlusion of Coronary Artery
    Keywords
    PET-CT, Cardiac magnetic resonance (CMR) imaging, Major adverse cardiac events (MACEs), coronary artery disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCI using stenting or balloon expansion
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Optimal medical therapy
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    stenting or balloon expansion
    Other Intervention Name(s)
    percutaneous coronary intervention
    Intervention Description
    all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
    Intervention Type
    Drug
    Intervention Name(s)
    aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes to myocardial viability
    Description
    Changes to myocardial viability from baseline assessed with the use of combined positron emission tomography and computerized tomography (PET-CT) system
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Major adverse cardiac events
    Description
    including all-cause mortality, cardiac death, first or recurrent acute myocardial infarction, recurrent angina, target lesion revascularization (TLR), heart failure, and re-hospitalization
    Time Frame
    12 months
    Title
    The rates of target vascular revascularization (TVR), TLR, and stent thrombosis
    Time Frame
    12 months
    Title
    Changes to left ventricular ejection fraction (LVEF)
    Description
    Changes to LVEF in % assessed with the use of cardiac MRI and transthoracic echocardiography (TTE).
    Time Frame
    12 months
    Title
    Changes to myocardial infarct size
    Description
    Changes to myocardial infarct size in percentage of total myocardial size assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to left ventricular mass (LVM)
    Description
    Changes to LVM in g assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to cardiac output (CO)
    Description
    Changes to cardiac CO in in L/min/m2 assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to stroke volume (SV)
    Description
    Changes to SV in ml assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to maximum left ventricular ejection rate
    Description
    Changes to maximum left ventricular ejection rate in % assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to maximum left ventricular filling rate
    Description
    Changes to maximum left ventricular filling rate in % assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to maximum slope
    Description
    Changes to maximum slope assessed with the use of cardiac MRI.
    Time Frame
    12 months
    Title
    Changes to left ventricular end-diastolic diameter (LVEDd)
    Description
    Changes to LVEDd in mm assessed with the use of TTE.
    Time Frame
    12 months
    Title
    Changes to left ventricular end-systolic diameter (LVESd)
    Description
    Changes to LVESd in mm assessed with the use of TTE.
    Time Frame
    12 months
    Title
    Changes to cardiac systolic function
    Description
    Changes to cardiac systolic function in E/A, E'/A', Ea/Aa, EDT in ms assessed with the use of TTE.
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Stroke incidence
    Time Frame
    12 months
    Title
    The number of compliant patients
    Description
    Compliant patients are usually defined as those who take predefined percentage (100%) of the treatment
    Time Frame
    12 months
    Title
    The total cost of medical care
    Description
    The total cost of medical care include equipment and medication in dollars.
    Time Frame
    12 months
    Title
    Number of guidewires
    Description
    Number of guidewires used in the procedure
    Time Frame
    12 months
    Title
    Number of balloons
    Description
    Number of balloons used in the procedure
    Time Frame
    12 months
    Title
    Number of stents
    Description
    Number of stents used in the procedure
    Time Frame
    12 months
    Title
    the volume of contrast
    Description
    the volume of contrast in ml during the procedure
    Time Frame
    12 months
    Title
    type of device
    Description
    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.
    Time Frame
    12 months
    Title
    the composite number of special techniques used in the procedure
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rongchong Huang, M.D.
    Organizational Affiliation
    The First Affiliated Hospital of Dalian Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25796024
    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.
    Results Reference
    background
    PubMed Identifier
    26029338
    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.
    Results Reference
    background
    PubMed Identifier
    26017064
    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.
    Results Reference
    background

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

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