Cardiac RevascularizationNCT04639856
ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting
A study testing Coronary Artery Bypass Grafting in people with Cardiac Revascularization, run by Armed Forces Institute of Cardiology, Pakistan at 1 site in Pakistan.
Trial summary
Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiac Revascularization
- What is being tested?
- Coronary Artery Bypass Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2018to 15 Jan 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of either gender between the ages of 40 to 80
- Ejection fraction of less than or equal to 35% undergoing CABG.
- undergoing CABG.
Who cannot join
- Patients with ejection fraction of more than 35%
- Patients with previous history of cardiac revascularization
- Patients with previous history of chronic kidney disease and obstructive sleep apnea.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Cardiology, Rawalpindi
Rawalpindi, 44000
About this study
Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads to a systemic inflammatory response, which may be induced by the contact of circulating blood with artificial surfaces of the extracorporeal circuit.[1] To reduce postoperative complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. [1] There are many studies and debates about the two approaches to cardiac revascularization via CABG. This study aims to answer the question as to difference in the ICU stay of patients with low ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary artery bypass grafting and better treatment option shall be adopted in future.
- Conditions
- Cardiac Revascularization
- Being tested
- Coronary Artery Bypass Grafting
- Keywords
- Coronary Artery Bypass Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass GraftingProcedure or surgery
on-pump vs off pump Coronary artery Bypass Grafting
| Study group | Role | What they receive |
|---|---|---|
| on-pump CABG | Active comparator | CABG using Cardiopulmonary Bypass Machine Receives: Procedure: Coronary Artery Bypass Grafting |
| off-pump CABG | Active comparator | CABG without Cardiopulmonary Bypass Machine Receives: Procedure: Coronary Artery Bypass Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Stay
post operative ICU stay in patients undergoing cardiac revascularization
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start15 Jul 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RevascularizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Cardiology, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Bilal, Armed Forces Institute of Cardiology, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639856
- Sponsor's protocol ID
- AFIC-IERB-SOP-15
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT04639856
- Acronym / sponsor ID
- AFIC-IERB-SOP-15
- Conditions
- Cardiac Revascularization
- Keywords
- Coronary Artery Bypass Grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Armed Forces Institute of Cardiology, PakistanUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 23 Nov 2020 (actual)
- 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.
Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads to a systemic inflammatory response, which may be induced by the contact of circulating blood with artificial surfaces of the extracorporeal circuit.[1] To reduce postoperative complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. [1] There are many studies and debates about the two approaches to cardiac revascularization via CABG. This study aims to answer the question as to difference in the ICU stay of patients with low ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary artery bypass grafting and better treatment option shall be adopted in future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on-pump CABG | Active comparator | Procedure: Coronary Artery Bypass GraftingCABG using Cardiopulmonary Bypass Machine |
| off-pump CABG | Active comparator | Procedure: Coronary Artery Bypass GraftingCABG without Cardiopulmonary Bypass Machine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients of either gender between the ages of 40 to 80
- Ejection fraction of less than or equal to 35% undergoing CABG.
- undergoing CABG.
Key exclusion criteria (3 listed)
- Patients with ejection fraction of more than 35%
- Patients with previous history of cardiac revascularization
- Patients with previous history of chronic kidney disease and obstructive sleep apnea.
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 |
|---|---|---|
| Coronary Artery Bypass Graftingon-pump vs off pump Coronary artery Bypass Grafting | Procedure or surgery | off-pump CABG, on-pump CABG |
Primary outcome
ICU Stay
Time frame: 6 Months
post operative ICU stay in patients undergoing cardiac revascularization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: Yes
Related trials for Cardiac Revascularization
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
Not yet recruiting
The CORE Platform Trial
Coronary Revascularization, Coronary Artery Disease
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Artery Bypass Grafting in people with Cardiac Revascularization, run by Armed Forces Institute of Cardiology, Pakistan at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Stay (time frame: 6 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 23 Nov 2020.