The SHINE-CTO Trial

Study Overview
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Brief Summary
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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

Official Title
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SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial

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

Intervention / Treatment
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* Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
* Procedure: Sham Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI of CTO<br>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<br>* Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice<br>|
| Sham Comparator: Sham Procedure<br>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<br>* Sham Procedure: Bilateral arterial access, without angiography or PCI being performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis |  | 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 |  | Baseline and 6 months | 
| Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D) |  | Baseline and 6 months | 
| Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score |  | Baseline and 6 months | 
| Greater improvement in exercise capacity, as assessed by treadmill exercise stress |  | Prior to and 1 month after index procedure | 
| Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term |  | 6 months | 
| Favorable incremental cost-effectiveness ratio |  | Through study completion, an average of 6 months |