The SHINE-CTO Trial

Minneapolis Heart Institute Foundation

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

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

Interventions

Chronic Total Occlusion Percutaneous Coronary InterventionPROCEDURE

Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice

Sham ProcedurePROCEDURE

Sham Procedure: Bilateral arterial access, without angiography or PCI being performed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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