Patency-Coronary Trial (PATENCY)

March 25, 2014 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

PATency assessmENt of Grafts by Computerized tomographY in CORONARY Patients: the PATENCY-CORONARY Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: As Coronary Artery Bypass Grafting (CABG) aims to restore adequate blood supply to the ischemic heart, the success of the operation should depend mainly on the patency of the bypass grafts. Graft failure has consequences similar to those of native coronary artery disease: recurrent angina, myocardial infarct (MI), additional revascularization procedures, and premature death. CABG is generally performed using cardiopulmonary bypass (CPB) with cardioplegic arrest allowing the surgeon to complete the delicate coronary anastomoses on a still heart in a bloodless field. Off-pump CABG surgery using specially designed heart stabilizer systems has been proposed as a less invasive approach to CABG avoiding the CPB circuit itself. The benefits of off-pump CABG compared with conventional on-pump CABG are still intensively debated. Multislice spiral computed tomography angiography (CTA) represents a non-invasive method as compared to conventional coronary angiography allowing a comprehensive and objective imaging of bypass grafts and native coronaries with elevated diagnostic accuracy.

Rationale: CORONARY trial (NCT00463294) is a large, international, prospective, CIHR-funded, randomized controlled trial assessing both the short and long-term clinical outcomes of 4,700 patients undergoing on-pump or off-pump CABG. However, angiographic evaluation of coronary graft patency was not intended in CORONARY.

Objectives: PATENCY-CORONARY is a new prospective trial of a consecutive subset of 1,200 CORONARY patients reaching their one-year follow-up who will undergo graft patency assessment using CTA and 3D reconstructions. This trial will determine whether off-pump compared to on-pump CABG surgery is associated with lower CABG patency when performed by experienced surgeons and if there is an association between graft failure assessed by CTA, and the occurrence of CORONARY primary outcomes (composite of death, angina, MI, stroke, renal failure and new coronary revascularization [CABG or PCI]).

Primary outcome: CABG patency index (i.e. the percentage of patent [non-occluded] distal anastomoses out of the total number of distal anastomoses for all patients) at 1 year after CABG surgery by experienced surgeons; Secondary outcomes: 1) graft lesion severity on a 3-point scale at 1 year (mimicking the FitzGibbon grading ABO); and 2) percentage of patients with at least one occluded bypass graft at 1 year; Tertiary outcome: correlation between CTA findings (compromised grafts) with CORONARY primary outcomes(composite of death, angina, MI, stroke, renal failure and new coronary revascularization [CABG or PCI]), at one and five-year of follow-up post-CABG.

Methods: All CORONARY patients reaching their one-year follow-up will be included consecutively in the PATENCY-CORONARY trial until the target of 1,200 CTA is reached and reasons for exclusion will be noted prospectively to prevent selection bias. Amount of contrast agent used, radiation dose and potential morbidities during this imaging procedure will be recorded. Each CTA examination will be assessed by two experienced and blinded radiologists and each graft will be classified according to conduit type and portions: body of the graft, anastomoses and the distal native coronary bed. In addition of PATENCY-CORONARY outcome analyses, patients undergoing CTA will be compared to excluded patients (no CTA) and the overall cohort of patients.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Not yet recruiting
        • Population Health Research Institute
        • Contact:
          • Andre Lamy, MD
          • Phone Number: 40635 905-527-4322
          • Email: alamy1@mac.com
        • Contact:
        • Principal Investigator:
          • André Lamy, MD
    • Quebec
      • Montreal, Quebec, Canada, H2W1T8
        • Recruiting
        • Centre Hospitalier University de Montreal
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Louis Mathieu Stevens, MD
        • Principal Investigator:
          • Gilles Soulez, MD
        • Sub-Investigator:
          • Samer Mansour, MD

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:

•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 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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On-pump CABG
Procedure: On-pump CABG
Use of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG.
Experimental: Off-pump CABG
Procedure: Off-pump CABG
CABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart.
Other Names:
  • Beating heart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CABG Patency index
Time Frame: 12 months
CABG patency index (i.e. the percentage of patent [non-occluded] distal anastomoses out of the total number of distal anastomoses for all patients) at 1 year after CABG surgery by experienced surgeons.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft lesion severity
Time Frame: 12 months
Graft lesion severity on a 3-point scale at 1 year (mimicking the FitzGibbon grading ABO).
12 months
Patients with at least one occluded graft
Time Frame: 12 months
Percentage of patients with at least one occluded bypass graft at 1 year.
12 months
Grafts compromised and clinical outcomes
Time Frame: 12 months and 5 years
Correlation between CTA findings (compromised grafts) with clinical primary outcomes of CORONARY trial (Myocardial infarct, Stroke, death), at one and five-year of follow-up post-CABG.
12 months and 5 years

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

  • Principal Investigator: Nicolas Noiseux, MD, CRCHUM, Montreal University

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.

Helpful Links

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

August 1, 2011

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE10.151

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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