HYbrid CoronAry Revascularization in DiabeticS

NCT02504762 | Completed DMC

• 1 other identifier: 20150338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes; Heart Disease

Outcome Measures

Primary Outcomes (1)

• Assessing conventional CABG vs HCR in diabetic patients with multivessel CAD

  To determine whether a hybrid strategy to treat multivessel CAD in diabetics is more or less effective than conventional CABG

  Up to 24 months

Secondary Outcomes (4)

• ≥ 95% participant adherence

  Up to 24 months

• Minimizing procedural crossovers

  Up to 24 months

• ≥ 95% follow-up rate

  Up to 24 months

• Number of patients we can enroll in 1 year

  Up to 24 months

Study Arms (2)

Treatment: HCR

EXPERIMENTAL

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

Control: Conventional CABG

ACTIVE COMPARATOR

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

Interventions

Treatment PROCEDURE

Hybrid Coronary Intervention = MICS CABG + Percutaneous Coronary Intervention. This study is a surgical intervention, which does not involve a drug or device intervention.

Treatment: HCR

Control PROCEDURE

Conventional CABG. This study is a surgical intervention, which does not involve a drug or device intervention.

Control: Conventional CABG

Eligibility Criteria

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

You may qualify if:

• Male or Female, aged 18 years or older;
• Diabetes Mellitus (Type 1 or Type 2) undergoing treatment;
• 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;
• Angiographic lesion characteristics amenable to both PCI/DES and MICS CABG;
• Indication for revascularization based upon objective ischemia.

You may not qualify if:

• Severe congestive heart failure (class III or IV NYHA) at enrollment;
• Left ventricular ejection fraction less than 20%;
• Prior CABG surgery;
• Prior heart valve surgery;
• Prior PCI within the previous 6 months;
• Previous tuberculosis or trauma to the chest that may have caused adhesions or LITA damage;
• 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;
• Prior history of significant bleeding that might be expected to recur with MICS CABG or PCI/DES related anticoagulation;
• STEMI or Q-wave MI within 72 hours prior to enrollment;
• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting);
• Contraindication to either cCABG, MICS CABG, or PCI/DES because of a coexisting clinical condition;
• Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis;
• Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor;
• Dementia with a Mini Mental Status Examination (MMSE) score of \< 20;
• Extra-cardiac illness that is expected to limit survival to less than 5 years;

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

Division of Cardiac Surgery, University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (9)

• Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.

  PMID: 9571335 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Prevalence of overweight and obesity among adults with diagnosed diabetes--United States, 1988-1994 and 1999-2002. MMWR Morb Mortal Wkly Rep. 2004 Nov 19;53(45):1066-8.

  PMID: 15549021 BACKGROUND

• Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, Mitch W, Smith SC Jr, Sowers JR. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1999 Sep 7;100(10):1134-46. doi: 10.1161/01.cir.100.10.1134. No abstract available.

  PMID: 10477542 BACKGROUND

• Gu K, Cowie CC, Harris MI. Diabetes and decline in heart disease mortality in US adults. JAMA. 1999 Apr 14;281(14):1291-7. doi: 10.1001/jama.281.14.1291.

  PMID: 10208144 BACKGROUND

• Kawate R, Yamakido M, Nishimoto Y, Bennett PH, Hamman RF, Knowler WC. Diabetes mellitus and its vascular complications in Japanese migrants on the Island of Hawaii. Diabetes Care. 1979 Mar-Apr;2(2):161-70. doi: 10.2337/diacare.2.2.161.

  PMID: 520120 BACKGROUND

• Fox CS, Coady S, Sorlie PD, Levy D, Meigs JB, D'Agostino RB Sr, Wilson PW, Savage PJ. Trends in cardiovascular complications of diabetes. JAMA. 2004 Nov 24;292(20):2495-9. doi: 10.1001/jama.292.20.2495.

  PMID: 15562129 BACKGROUND

• Ruel M, Shariff MA, Lapierre H, Goyal N, Dennie C, Sadel SM, Sohmer B, McGinn JT Jr. Results of the Minimally Invasive Coronary Artery Bypass Grafting Angiographic Patency Study. J Thorac Cardiovasc Surg. 2014 Jan;147(1):203-8. doi: 10.1016/j.jtcvs.2013.09.016. Epub 2013 Oct 30.

  PMID: 24183338 BACKGROUND

• Verma S, Farkouh ME, Yanagawa B, Fitchett DH, Ahsan MR, Ruel M, Sud S, Gupta M, Singh S, Gupta N, Cheema AN, Leiter LA, Fedak PW, Teoh H, Latter DA, Fuster V, Friedrich JO. Comparison of coronary artery bypass surgery and percutaneous coronary intervention in patients with diabetes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 2013 Dec;1(4):317-28. doi: 10.1016/S2213-8587(13)70089-5. Epub 2013 Sep 13.

  PMID: 24622417 BACKGROUND

• Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056/NEJMoa1211585. Epub 2012 Nov 4.

  PMID: 23121323 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Heart Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Study Officials

• Marc Ruel, MD. MPH

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Surgeon

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)