Patency-Coronary Trial
PATENCY
PATency assessmENt of Grafts by Computerized tomographY in CORONARY Patients: the PATENCY-CORONARY Trial
1 other identifier
interventional
1,200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 26, 2014
March 1, 2014
3.4 years
August 9, 2011
March 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CABG Patency index
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 Outcomes (3)
Graft lesion severity
12 months
Patients with at least one occluded graft
12 months
Grafts compromised and clinical outcomes
12 months and 5 years
Study Arms (2)
On-pump CABG
EXPERIMENTALOff-pump CABG
EXPERIMENTALInterventions
Use of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG.
CABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart.
Eligibility Criteria
You may qualify if:
- All CORONARY (NCT00463294) patients reaching their one-year follow-up (9-24 months) will be included consecutively in the PATENCY-CORONARY trial.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, T2N 2T9, Canada
Population Health Research Institute
Hamilton, Ontario, L8L2X2, Canada
Centre Hospitalier University de Montreal
Montreal, Quebec, H2W1T8, Canada
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Noiseux, MD
CRCHUM, Montreal University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 11, 2011
Study Start
August 1, 2011
Primary Completion
January 1, 2015
Study Completion
September 1, 2015
Last Updated
March 26, 2014
Record last verified: 2014-03