The SHINE-CTO Trial (SHINE-CTO)

June 2, 2021 updated by: Minneapolis Heart Institute Foundation

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCI of CTO
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
Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
Sham Comparator: Sham Procedure
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
Sham Procedure: Bilateral arterial access, without angiography or PCI being performed

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis
Time Frame: 6 months
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
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
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
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
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
6 months
Favorable incremental cost-effectiveness ratio
Time Frame: Through study completion, an average of 6 months
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Investigators

  • Study Chair: Emmanouil S Brilakis, MD, PhD, Minneapolis Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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