Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty
Conditions
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
Interventions
Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
PROCEDURESham Procedure
Sham Procedure: Bilateral arterial access, without angiography or PCI being performed
Sponsors
Minneapolis Heart Institute Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis | 6 months |
| 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 |
| Greater improvement in exercise capacity, as assessed by treadmill exercise stress | Prior to and 1 month after index procedure |
Outcome results
None listed