Complications Due to Coronary Artery Bypass GraftPATENCYNCT01414049
Patency-Coronary Trial
A study testing On-pump CABG and Off-pump CABG in people with Complications Due to Coronary Artery Bypass Graft and Graft Failure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications Due to Coronary Artery Bypass Graft, Graft Failure
- What is being tested?
- On-pump CABG and Off-pump CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •All CORONARY (NCT00463294) patients reaching their one-year follow-up (9-24 months) will be included consecutively in the PATENCY-CORONARY trial.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, T2N 2T9
Teresa Keiser, MD, teresa.kieser@calgaryhealthregion.ca
Teresa Kieser, MD
- Not yet recruiting
Population Health Research Institute
Hamilton, Ontario, L8L2X2
Andre Lamy, MD, 905-527-4322 ext. 40635, alamy1@mac.com
Jessica Vincent, 905-527-4322 ext. 40635, jessica.vincent@phri.ca
- Recruiting
Centre Hospitalier University de Montreal
Montreal, Quebec, H2W1T8
Nicolas Noiseux, MD, 514-890-8131, noiseuxn@videotron.ca
Louis Mathieu Stevens, MD, 514-890-8131, lm.stevens@videotron.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- On-pump CABG, Off-pump CABG
- Keywords
- CABG, Off-pump CABG, Beating heart, Graft patency, Computed tomography angiography, Angiographic evaluation of coronary graft patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-pump CABGProcedure or surgery
Use of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG.
Off-pump CABGProcedure or surgery
Also called Beating heart
CABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart.
| Study group | Role | What they receive |
|---|---|---|
| On-pump CABG | Experimental | Not described Receives: Procedure: On-pump CABG |
| Off-pump CABG | Experimental | Not described Receives: Procedure: Off-pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Graft lesion severity
Graft lesion severity on a 3-point scale at 1 year (mimicking the FitzGibbon grading ABO).
Measured: 12 months
Patients with at least one occluded graft
Percentage of patients with at least one occluded bypass graft at 1 year.
Measured: 12 months
Grafts compromised and clinical outcomes
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.
Measured: 12 months and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications Due to Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Nicolas Noiseux, MD, Principal investigator, CRCHUM, Montreal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414049
- Sponsor's protocol ID
- CE10.151
- Acronym
- PATENCY
- Status last verified
- Mar 2014
- First submitted
- 9 Aug 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PATency assessmENt of Grafts by Computerized tomographY in CORONARY Patients: the PATENCY-CORONARY Trial
- ClinicalTrials.gov ID
- NCT01414049
- Acronym / sponsor ID
- PATENCY / CE10.151
- Keywords
- CABG, Off-pump CABG, Beating heart, Graft patency, Computed tomography angiography, Angiographic evaluation of coronary graft patency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- Aug 2011
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-pump CABG | Experimental | Procedure: On-pump CABG |
| Off-pump CABG | Experimental | Procedure: Off-pump CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •All CORONARY (NCT00463294) patients reaching their one-year follow-up (9-24 months) will be included consecutively in the PATENCY-CORONARY trial.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-pump CABGUse of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG. | Procedure or surgery | On-pump CABG |
| Off-pump CABGAlso: Beating heartCABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart. | Procedure or surgery | Off-pump CABG |
Primary outcome
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.
3 secondary outcomes
Graft lesion severity
Time frame: 12 months
Patients with at least one occluded graft
Time frame: 12 months
Grafts compromised and clinical outcomes
Time frame: 12 months and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- CORONARY trialLink provided by the sponsor.
Related trials for Complications Due to Coronary Artery Bypass Graft
Active, not recruiting
Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting
Drainage, Complications Due to Coronary Artery Bypass Graft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Noiseux, MD principal investigator
CRCHUM, Montreal University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-pump CABG and Off-pump CABG in people with Complications Due to Coronary Artery Bypass Graft and Graft Failure, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Noiseux, MD (514-890-8131, noiseuxn@videotron.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CABG Patency index (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.