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HYbrid CoronAry Revascularization in DiabeticS (HYCARDS)

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ClinicalTrials.gov Identifier: NCT02504762
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation

Brief Summary:
To evaluate whether an HCR strategy is more or less effective than conventional coronary artery bypass grafting (cCABG), in diabetic patients with multivessel CAD involving the left anterior descending artery (LAD), who do not present in the context of acute ST-elevation myocardial infarction (STEMI).

Condition or disease Intervention/treatment Phase
Diabetes Heart Disease Procedure: Treatment Procedure: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HYbrid CoronAry Revascularization in DiabeticS: A Randomized Controlled Trial (Pilot)
Study Start Date : August 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Treatment: HCR
Participants will be randomized into the treatment or control group. In the treatment group, participants will be treated with PCI and MICS CABG. In the control group, participants will be treated with conventional CABG for their multivessel CAD.
Procedure: Treatment
Hybrid Coronary Intervention = MICS CABG + Percutaneous Coronary Intervention. This study is a surgical intervention, which does not involve a drug or device intervention.

Active Comparator: Control: Conventional CABG
Participants will be randomized into the treatment or control group. In the treatment group, participants will be treated with PCI and MICS CABG. In the control group, participants will be treated with conventional CABG for their multivessel CAD.
Procedure: Control
Conventional CABG. This study is a surgical intervention, which does not involve a drug or device intervention.




Primary Outcome Measures :
  1. Assessing conventional CABG vs HCR in diabetic patients with multivessel CAD [ Time Frame: Up to 24 months ]
    To determine whether a hybrid strategy to treat multivessel CAD in diabetics is more or less effective than conventional CABG


Secondary Outcome Measures :
  1. ≥ 95% participant adherence [ Time Frame: Up to 24 months ]
    Adherence defined as ≥ 95% of the prescribed randomized revascularization index

  2. Minimizing procedural crossovers [ Time Frame: Up to 24 months ]
    Minimization of procedural crossovers in regards to patients crossing from one modality to the other, prior, during, or early failure of the planned, assigned index procedure

  3. ≥ 95% follow-up rate [ Time Frame: Up to 24 months ]
    One year follow-up rates will be ≥ 95%

  4. Number of patients we can enroll in 1 year [ Time Frame: Up to 24 months ]
    How many eligible and consenting patients can be successfully enrolled in 1 year, and followed-up for 1 year



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female, aged 18 years or older;
  2. Diabetes Mellitus (Type 1 or Type 2) undergoing treatment;
  3. Multivessel disease involving the LAD + at least one other coronary territory (stenosis ≥ 70% in a 1.5 mm artery) in a patient referred for cCABG;
  4. Angiographic lesion characteristics amenable to both PCI/DES and MICS CABG;
  5. Indication for revascularization based upon objective ischemia.

Exclusion Criteria:

  1. Severe congestive heart failure (class III or IV NYHA) at enrollment;
  2. Left ventricular ejection fraction less than 20%;
  3. Prior CABG surgery;
  4. Prior heart valve surgery;
  5. Prior PCI within the previous 6 months;
  6. Previous tuberculosis or trauma to the chest that may have caused adhesions or LITA damage;
  7. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected by a Rankin Score > 1;
  8. Prior history of significant bleeding that might be expected to recur with MICS CABG or PCI/DES related anticoagulation;
  9. STEMI or Q-wave MI within 72 hours prior to enrollment;
  10. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting);
  11. Contraindication to either cCABG, MICS CABG, or PCI/DES because of a coexisting clinical condition;
  12. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
  13. Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor;
  14. Dementia with a Mini Mental Status Examination (MMSE) score of < 20;
  15. Extra-cardiac illness that is expected to limit survival to less than 5 years;
  16. Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal;
  17. Concurrent enrollment in another clinical trial;
  18. Geographic inaccessibility for the follow-up visits required by protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504762


Contacts
Contact: Marc Ruel, MD, MPH 613-761-4893 MRuel@ottawaheart.ca

Locations
Canada, Ontario
Division of Cardiac Surgery, University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Marc Ruel, MD MPH FRCSC    613-761-4893    mruel@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Marc Ruel, MD. MPH Ottawa Heart Institute Research Corporation

Publications:

Responsible Party: Marc Ruel MD MPH FRCSC, Cardiac Surgeon, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02504762     History of Changes
Other Study ID Numbers: 20150338
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Findings from this study will be presented at conferences.

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases