CAD - Coronary Artery DiseaseNCT05442723
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
A study testing On-Pump CABG and Off-Pump CABG in people with CAD - Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
Trial summary
Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- CAD - Coronary Artery Disease
- 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
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2022to 1 Mar 2023
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any patient with diffuse LAD disease indicated for open heart surgery
Who cannot join
- no concomitant valve disease
- any patient can be treated by medical treatment or PCI
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university heart hospital
Asyut, 2112
Kareem Ahmed Hosny, Bachelor of medicine, 01000401994, kareemdna94@gmail.com
About this study
Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.
- Conditions
- CAD - Coronary Artery Disease
- Being tested
- On-Pump CABG, Off-Pump CABG
- Keywords
- On-pump, off-pump, CABG, LAD
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-Pump CABGProcedure or surgery
Also called CABG
coronary artery grafting by using cardiopulmonary bypass machine
Off-Pump CABGProcedure or surgery
coronary artery grafting by beating heart technique
| Study group | Role | What they receive |
|---|---|---|
| Case | Other | Patients with extensive LAD disease treated with off-pump CABG Receives: Procedure: Off-Pump CABG |
| Control | Other | Patients with extensive LAD disease treated with on-pump CABG Receives: Procedure: On-Pump CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
follow up post-operative track of the patient for any noticed mortality rate
Measured: 30 days post operative
Morbidity
follow up post-operative track of the patient for any noticed complications
Measured: 60 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start25 Feb 2022
- Primary completion24 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ahmed Hosny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442723
- Sponsor's protocol ID
- AssiutMed
- Status last verified
- Jun 2022
- First submitted
- 26 Feb 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?
- ClinicalTrials.gov ID
- NCT05442723
- Acronym / sponsor ID
- AssiutMed
- Conditions
- CAD - Coronary Artery Disease
- Keywords
- On-pump, off-pump, CABG, LAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 24 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 5 Jul 2022 (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.
Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Other | Procedure: Off-Pump CABGPatients with extensive LAD disease treated with off-pump CABG |
| Control | Other | Procedure: On-Pump CABGPatients with extensive LAD disease treated with on-pump CABG |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient with diffuse LAD disease indicated for open heart surgery
Key exclusion criteria (2 listed)
- no concomitant valve disease
- any patient can be treated by medical treatment or PCI
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 CABGAlso: CABGcoronary artery grafting by using cardiopulmonary bypass machine | Procedure or surgery | Control |
| Off-Pump CABGcoronary artery grafting by beating heart technique | Procedure or surgery | Case |
Primary outcome
mortality
Time frame: 30 days post operative
follow up post-operative track of the patient for any noticed mortality rate
Morbidity
Time frame: 60 days post operative
follow up post-operative track of the patient for any noticed complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
1 site 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 CAD - Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
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 2 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 5 Jul 2022. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days post operative). The study lists 2 primary outcomes in all. 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 5 Jul 2022.