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Coronary Artery DiseaseSHINE-CTONCT02784418

The SHINE-CTO Trial

A study testing Chronic Total Occlusion Percutaneous Coronary Intervention in people with Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Minneapolis Heart Institute Foundation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chronic Total Occlusion Percutaneous Coronary Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
May 2016to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

Official title: 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.

Read more

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

Being tested
Chronic Total Occlusion Percutaneous Coronary Intervention, Sham Procedure
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronic Total Occlusion Percutaneous Coronary InterventionProcedure or surgery

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

  • Sham ProcedureProcedure or surgery

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

Study groups in NCT02784418
Study groupRoleWhat they receive
PCI of CTOActive comparatorIntervention: 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.
Receives: Procedure: Chronic Total Occlusion Percutaneous Coronary Intervention
Sham ProcedureSham comparatorIntervention: 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.
Receives: Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 month

Secondary outcomes (7)

  1. Greater improvement in SAQ-7 Summary scores during the entire duration of follow-up using a repeated measures analysis

    Measured: 6 months

  2. 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

    Measured: Baseline and 6 months

  3. Greater improvement in individual components of patients' health status, as assessed by the EuroQol-5D (EQ-5D)

    Measured: Baseline and 6 months

  4. Greater improvement in individual components of patients' health status, as assessed by the Rose Dyspnea Score

    Measured: Baseline and 6 months

  5. Greater improvement in exercise capacity, as assessed by treadmill exercise stress

    Measured: Prior to and 1 month after index procedure

  6. Similar incidence of major adverse cardiac events (MACE), both peri-procedural and long-term

    Measured: 6 months

  7. Favorable incremental cost-effectiveness ratio

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Funding issues due to the pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784418
Sponsor's protocol ID
16-009
Acronym
SHINE-CTO
Status last verified
Jun 2021
First submitted
20 May 2016
Last updated
7 Jun 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22516392

  • 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.

    PubMed 8362709

  • 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.

    PubMed 15842978

  • 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.

    PubMed 19294443

  • 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.

    PubMed 20388873

  • 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.

    PubMed 20598990

Questions about this trial

What is this clinical trial studying?

A study testing Chronic Total Occlusion Percutaneous Coronary Intervention in people with Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Minneapolis Heart Institute Foundation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784418, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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