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The SHINE-CTO Trial (SHINE-CTO)

Primary Purpose

Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Transluminal Coronary Angioplasty

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chronic Total Occlusion Percutaneous Coronary Intervention
Sham Procedure
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or greater
  • Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
  • Referred for clinically-indicated CTO PCI
  • Optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin)

Exclusion Criteria:

  • Coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol
  • Recent (<7 days) acute myocardial infarction
  • Patient has no symptoms related to the CTO
  • Known allergy to aspirin or clopidogrel
  • Increased risk of bleeding (need for warfarin, oral Xa inhibitor, or thrombin inhibitor administration, recent [within 30 days] major bleed, known bleeding diathesis or coagulation disorder)
  • Positive pregnancy test or breast-feeding
  • Chronic kidney disease, defined as serum creatinine > 2.5 mg/dL
  • Severe peripheral arterial disease limiting exercise capacity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    PCI of CTO

    Sham Procedure

    Arm Description

    Intervention: PCI of CTO (Chronic Total Occlusion Percutaneous Coronary Intervention) Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. CTO PCI patients will receive blinded clopidogrel 75 mg daily for 6 months.

    Intervention: Sham procedure Subjects will be blinded to randomization assignment using a combination of conscious sedation and sensory isolation (e.g., blindfold and noise isolation). Control subjects will only undergo a "Sham procedure", wherein they will undergo bilateral arterial access, without angiography or PCI being performed. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. Sham group will receive blinded placebo clopidogrel for 6 months.

    Outcomes

    Primary Outcome Measures

    Greater improvement in disease-specific health status, as assessed by the 7-item Seattle Angina Questionnaire (SAQ) Summary Score (SAQ-7, an established measure of health status in patients with coronary artery disease)

    Secondary Outcome Measures

    Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis
    Greater improvement in individual components of patients' health status, as assessed by the SAQ Physical Limitation, Angina Frequency, and Quality of Life domains of the SAQ-7 score
    Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)
    Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score
    Greater improvement in exercise capacity, as assessed by treadmill exercise stress
    Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
    Favorable incremental cost-effectiveness ratio

    Full Information

    First Posted
    May 20, 2016
    Last Updated
    June 2, 2021
    Sponsor
    Minneapolis Heart Institute Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02784418
    Brief Title
    The SHINE-CTO Trial
    Acronym
    SHINE-CTO
    Official Title
    SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding issues due to the pandemic
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Minneapolis Heart Institute Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention (PCI) or a sham procedure. All patients will receive optimal medical therapy. Treatment:CTO PCI, as per standard clinical practice. Control: Patients randomized to sham-procedure will undergo only bilateral arterial access, without angiography or PCI being performed. Secondary Endpoints: (1) Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up (6 months) using a repeated measures analysis (2) Greater improvement in individual components of patients' health status (3) Greater improvement in exercise capacity (4) Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Transluminal Coronary Angioplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PCI of CTO
    Arm Type
    Active Comparator
    Arm Description
    Intervention: PCI of CTO (Chronic Total Occlusion Percutaneous Coronary Intervention) Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. CTO PCI patients will receive blinded clopidogrel 75 mg daily for 6 months.
    Arm Title
    Sham Procedure
    Arm Type
    Sham Comparator
    Arm Description
    Intervention: Sham procedure Subjects will be blinded to randomization assignment using a combination of conscious sedation and sensory isolation (e.g., blindfold and noise isolation). Control subjects will only undergo a "Sham procedure", wherein they will undergo bilateral arterial access, without angiography or PCI being performed. Hospitalized overnight after the procedure, with post procedure monitoring practices as per standard of care for PCI. Sham group will receive blinded placebo clopidogrel for 6 months.
    Intervention Type
    Procedure
    Intervention Name(s)
    Chronic Total Occlusion Percutaneous Coronary Intervention
    Intervention Description
    Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham Procedure
    Intervention Description
    Sham Procedure: Bilateral arterial access, without angiography or PCI being performed
    Primary Outcome Measure Information:
    Title
    Greater improvement in disease-specific health status, as assessed by the 7-item Seattle Angina Questionnaire (SAQ) Summary Score (SAQ-7, an established measure of health status in patients with coronary artery disease)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis
    Time Frame
    6 months
    Title
    Greater improvement in individual components of patients' health status, as assessed by the SAQ Physical Limitation, Angina Frequency, and Quality of Life domains of the SAQ-7 score
    Time Frame
    Baseline and 6 months
    Title
    Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)
    Time Frame
    Baseline and 6 months
    Title
    Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score
    Time Frame
    Baseline and 6 months
    Title
    Greater improvement in exercise capacity, as assessed by treadmill exercise stress
    Time Frame
    Prior to and 1 month after index procedure
    Title
    Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
    Time Frame
    6 months
    Title
    Favorable incremental cost-effectiveness ratio
    Time Frame
    Through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or greater Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up. Referred for clinically-indicated CTO PCI Optimal medical therapy (at least two anti-anginal medications at maximum tolerated doses, aspirin, and statin) Exclusion Criteria: Coexisting conditions that limit life expectancy to less than 6 months or that could affect a patient's compliance with the protocol Recent (<7 days) acute myocardial infarction Patient has no symptoms related to the CTO Known allergy to aspirin or clopidogrel Increased risk of bleeding (need for warfarin, oral Xa inhibitor, or thrombin inhibitor administration, recent [within 30 days] major bleed, known bleeding diathesis or coagulation disorder) Positive pregnancy test or breast-feeding Chronic kidney disease, defined as serum creatinine > 2.5 mg/dL Severe peripheral arterial disease limiting exercise capacity
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emmanouil S Brilakis, MD, PhD
    Organizational Affiliation
    Minneapolis Heart Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22516392
    Citation
    Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
    Results Reference
    background
    PubMed Identifier
    8362709
    Citation
    Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.
    Results Reference
    background
    PubMed Identifier
    15842978
    Citation
    Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
    Results Reference
    background
    PubMed Identifier
    19294443
    Citation
    Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
    Results Reference
    background
    PubMed Identifier
    20388873
    Citation
    Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13.
    Results Reference
    background
    PubMed Identifier
    20598990
    Citation
    Joyal D, Afilalo J, Rinfret S. Effectiveness of recanalization of chronic total occlusions: a systematic review and meta-analysis. Am Heart J. 2010 Jul;160(1):179-87. doi: 10.1016/j.ahj.2010.04.015.
    Results Reference
    background

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    The SHINE-CTO Trial

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