The SHINE-CTO Trial

Coronary Artery Disease Clinical Trial

— SHINE-CTO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02784418
• Other study ID #: 16-009
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Chronic Total Occlusion Percutaneous Coronary Intervention
Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
• Sham Procedure
Sham Procedure: Bilateral arterial access, without angiography or PCI being performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

References & 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

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