Recruiting

Coronary Trial

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT01414049

Conditions

Complications Due to Coronary Artery Bypass Graft

Graft Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

On-pump CABG

Off-pump CABG

Study Details

Brief summary:

Heart bypass surgery is used to increase blood flow to the heart. This surgery is usually done using a heart-lung machine (on-pump surgery) allowing the surgeon to perform the procedure on a still heart. However, this heart-lung machine causes an inflammatory response and is linked with complications such as heart injury, stroke, brain injury, kidney failure, need for blood transfusions, irregular heart rhythms and death. An effective way of counteracting the effects of the heart-lung machine is to not use the pump itself, thus performing the bypass surgery with a beating heart (off-pump surgery). However, off-pump surgery is technically more difficult, possibly associated with a decrease in graft patency. The ongoing Coronary Artery Bypass Graft Off or On Pump Revascularization Study (CORONARY), is a prospective randomized clinical trial comparing bypass surgery done with and without the pump. Worldwide, 4700 patients will be included and followed up for 5 years. The proposed research project, The Patency AssessmenT of grafts pErformed iN CORONARY (PATENCY-CORONARY), is a prospective clinical trial for the evaluation of patency (or "openness") of the bypass grafts that will enrol 1200 consecutive CORONARY patients reaching their one year follow-up. Patients will undergo a non-invasive scan using X-rays to safely and quickly evaluate graft patency. The PATENCY-CORONARY trial will determine if off-pump surgery is associated with decreased graft patency at 1-year post-surgery compared to on-pump surgery when performed by skilled surgeons in different clinical settings, whether decreased graft patency is associated with adverse short and long-term outcomes, and explore other risk factors associated with decreased graft patency.

Conditions

Complications Due to Coronary Artery Bypass Graft

Graft Failure

Study ID

NCT01414049

Start date

Aug, 2011

Status verified date

Mar, 2014

Completion date

Sep, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

•All CORONARY (NCT00463294) patients reaching their one-year follow-up (9-24 months) will be included consecutively in the PATENCY-CORONARY trial.

Exclusion Criteria:

  • Has a history of severe hypersensitivity to iodinated contrast agents;
  • Has known or suspected for pheochromocytoma;
  • Has severe renal impairment (estimated glomerular filtration rate, eGFR <35 mL/min/1.73 m2). Patients with eGFR 35-50 mL/min/1.73 m2 will be treated with hydratation and N-acetylcysteine (Mucomyst®) as per local protocol for contrast administration;
  • Has rapid atrial fibrillation or any other cardiac rhythm that precludes reliable ECG triggering;
  • Has severe congestive heart failure, New York Heart Association (NYHA) Class IV;
  • Is a pregnant or lactating female.

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: On-pump CABG

experimental: Off-pump CABG

Interventions

On-pump CABG

Use of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG.

Off-pump CABG

CABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart.

Primary outcome measure

  • CABG Patency index [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Centre Hospitalier University de Montreal

Recruiting

Montreal, Quebec, Canada, H2W1T8

Contacts

Principal Investigator:

Gilles Soulez, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 26, 2014

Last verified

Mar, 2014

Keywords

  • CABG
  • Off-pump CABG
  • Beating heart
  • Graft patency
  • Computed tomography angiography
  • Angiographic evaluation of coronary graft patency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2014-03-26.