Trial record 3 of 46 for:    shine

The SHINE-CTO Trial (SHINE-CTO)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT02784418
First received: May 20, 2016
Last updated: May 24, 2016
Last verified: May 2016
  Purpose

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


Condition Intervention
Coronary Artery Disease
Chronic Total Occlusion of Coronary Artery
Percutaneous Transluminal Coronary Angioplasty
Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
Procedure: Sham Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

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) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Greater improvement in exercise capacity, as assessed by treadmill exercise stress [ Time Frame: Prior to and 1 month after index procedure ] [ Designated as safety issue: No ]
  • Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Favorable incremental cost-effectiveness ratio [ Time Frame: Through study completion, an average of 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: May 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
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.
Procedure: Sham Procedure
Sham Procedure: Bilateral arterial access, without angiography or PCI being performed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02784418

Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Study Chair: Emmanouil S Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

Publications:

Responsible Party: Emmanouil Brilakis, Director of Cardiac Catheterization Laboratories, Professor of Medicine, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT02784418     History of Changes
Other Study ID Numbers: 16-009 
Study First Received: May 20, 2016
Last Updated: May 24, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016