The SHINE-CTO Trial

NCT02784418 | Withdrawn DMC

• 1 other identifier: 16-009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

PCI of CTO

ACTIVE COMPARATOR

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

Sham Procedure

SHAM COMPARATOR

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

Interventions

Chronic Total Occlusion Percutaneous Coronary Intervention PROCEDURE

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

PCI of CTO

Sham Procedure PROCEDURE

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

Sham Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Related Publications (6)

• 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.

  PMID: 22516392 BACKGROUND

• 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.

  PMID: 8362709 BACKGROUND

• 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.

  PMID: 15842978 BACKGROUND

• 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.

  PMID: 19294443 BACKGROUND

• 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.

  PMID: 20388873 BACKGROUND

• 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.

  PMID: 20598990 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Emmanouil S Brilakis, MD, PhD

  Minneapolis Heart Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share