Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Patency-Coronary Trial (PATENCY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01414049
First received: August 9, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Complications Due to Coronary Artery Bypass Graft
Graft Failure
Procedure: On-pump CABG
Procedure: Off-pump CABG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: PATency assessmENt of Grafts by Computerized tomographY in CORONARY Patients: the PATENCY-CORONARY Trial

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • CABG Patency index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Graft lesion severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Graft lesion severity on a 3-point scale at 1 year (mimicking the FitzGibbon grading ABO).

  • Patients with at least one occluded graft [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of patients with at least one occluded bypass graft at 1 year.

  • Grafts compromised and clinical outcomes [ Time Frame: 12 months and 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: August 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Beating heart

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414049

Contacts
Contact: Nicolas Noiseux, MD 514-890-8131 noiseuxn@videotron.ca
Contact: Louis Mathieu Stevens, MD 514-890-8131 lm.stevens@videotron.ca

Locations
Canada, Alberta
Libin Cardiovascular Institute of Alberta Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Teresa Keiser, MD       teresa.kieser@calgaryhealthregion.ca   
Sub-Investigator: Teresa Kieser, MD         
Canada, Ontario
Population Health Research Institute Not yet recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: Andre Lamy, MD    905-527-4322 ext 40635    alamy1@mac.com   
Contact: Jessica Vincent    905-527-4322 ext 40635    jessica.vincent@phri.ca   
Principal Investigator: André Lamy, MD         
Canada, Quebec
Centre Hospitalier University de Montreal Recruiting
Montreal, Quebec, Canada, H2W1T8
Contact: Nicolas Noiseux, MD    514-890-8131    noiseuxn@videotron.ca   
Contact: Louis Mathieu Stevens, MD    514-890-8131    lm.stevens@videotron.ca   
Sub-Investigator: Louis Mathieu Stevens, MD         
Sub-Investigator: Carl Chartrand-Lefebvre, MD         
Principal Investigator: Gilles Soulez, MD         
Principal Investigator: Nicolas Noiseux, MD         
Sub-Investigator: Samer Mansour, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Nicolas Noiseux, MD CRCHUM, Montreal University
  More Information

Additional Information:
No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01414049     History of Changes
Other Study ID Numbers: CE10.151
Study First Received: August 9, 2011
Last Updated: March 25, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
CABG
Off-pump CABG
Beating heart
Graft patency
Computed tomography angiography
Angiographic evaluation of coronary graft patency

ClinicalTrials.gov processed this record on November 25, 2014