Clinical trial NCT02784418: The SHINE-CTO Trial
Official title: SHam-controlled INtErvention to Improve QOL in CTOs: the SHINE CTO Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Chronic Total Occlusion of Coronary Artery
Percutaneous Transluminal Coronary Angioplasty
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 1 month
Secondary outcomes:
measure: Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis
timeFrame: 6 months
measure: 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
timeFrame: Baseline and 6 months
measure: Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)
timeFrame: Baseline and 6 months
measure: Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score
timeFrame: Baseline and 6 months
measure: Greater improvement in exercise capacity, as assessed by treadmill exercise stress
timeFrame: Prior to and 1 month after index procedure
measure: Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term
timeFrame: 6 months
measure: Favorable incremental cost-effectiveness ratio
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Minneapolis Heart Institute
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_CHAIR
References:
citation: Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
citation: Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4. doi: 10.1016/0002-8703(93)90404-w.
citation: Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
citation: Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
citation: Grantham JA, Jones PG, Cannon L, Spertus JA. Quantifying the early health status benefits of successful chronic total occlusion recanalization: Results from the FlowCardia's Approach to Chronic Total Occlusion Recanalization (FACTOR) Trial. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):284-90. doi: 10.1161/CIRCOUTCOMES.108.825760. Epub 2010 Apr 13.
citation: Joyal D, Afilalo J, Rinfret S. Effectiveness of recanalization of chronic total occlusions: a systematic review and meta-analysis. Am Heart J. 2010 Jul;160(1):179-87. doi: 10.1016/j.ahj.2010.04.015.