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The SHINE-CTO Trial (SHINE-CTO)

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ClinicalTrials.gov Identifier: NCT02784418
Recruitment Status : Withdrawn (Funding issues due to the pandemic)
First Posted : May 27, 2016
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE May 27, 2016
Last Update Posted Date June 7, 2021
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis [ Time Frame: 6 months ]
  • 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 ]
  • Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D) [ Time Frame: Baseline and 6 months ]
  • Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score [ Time Frame: Baseline and 6 months ]
  • Greater improvement in exercise capacity, as assessed by treadmill exercise stress [ Time Frame: Prior to and 1 month after index procedure ]
  • Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term [ Time Frame: 6 months ]
  • Favorable incremental cost-effectiveness ratio [ Time Frame: Through study completion, an average of 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The SHINE-CTO Trial
Official Title  ICMJE SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery
  • Percutaneous Transluminal Coronary Angioplasty
Intervention  ICMJE
  • Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
    Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
  • Procedure: Sham Procedure
    Sham Procedure: Bilateral arterial access, without angiography or PCI being performed
Study Arms  ICMJE
  • Active Comparator: PCI of CTO
    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: Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
  • Sham Comparator: Sham Procedure
    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: Procedure: Sham Procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 2, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
142
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02784418
Other Study ID Numbers  ICMJE 16-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Minneapolis Heart Institute Foundation
Study Sponsor  ICMJE Minneapolis Heart Institute Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Emmanouil S Brilakis, MD, PhD Minneapolis Heart Institute
PRS Account Minneapolis Heart Institute Foundation
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP