Coronary Artery Disease Left MainNCT04439162
Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
A study testing retrograde cardioplegia protection in people with Coronary Artery Disease Left Main, run by Assiut University.
Trial summary
During coronary artery bypass surgery, myocardial protection, especially of the right ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the antegrade delivery of cold cardioplegia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Coronary Artery Disease Left Main
- What is being tested?
- retrograde cardioplegia protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Apr 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- LV ejection fraction between 30 and 50%
- left main stem CAD
- mitral or aortic valve disease associated with ischemic heart disease
Who cannot join
- Double valve disease or other valve disease
- mitral or aortic valve disease associated with congenital heart disease
- patients subjected to prior heart surgery
- emergency operation
- poorly controlled diabetes mellitus
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Results of Combined Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
During coronary artery bypass surgery, myocardial protection, especially of the right ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the antegrade delivery of cold cardioplegia
Read the detailed description
Asymetric myocardial cooling has been reported to yield postoperative right ventricular dysfunction, which may contribute to postoperative morbidity and mortality. Retrograde coronary sinus perfusion was introduced in 1956 to facilitate surgery involving the aortic valve. This technique was introduced as a means of myocardial protection for coronary artery bypass surgery in 1967 and has recently received renewed interest. An innovative method of delivering retrograde cardioplegia through the right atrium was recently developed by Fabiani and associates. This technique has obviated the need to directly cannulate the coronary sinus and thus has eliminated concerns regarding coronary sinus rupture due to cannulation, and concerns of inadequate right ventricular perfusion. In contrast to antegrade delivery, retrograde delivery of cardioplegia through the right atrium is not subject to the problem of limited distribution in the presence of coronary artery occlusive disease and thus allows more uniform cooling of the left ventricle,so the study will compare the results of combined antegrade and retrograde versurs antegrade cardioplegia in complex coronary artery bypass surgeries
- Conditions
- Coronary Artery Disease Left Main
- Being tested
- retrograde cardioplegia protection
- 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.
retrograde cardioplegia protectionProcedure or surgery
antegrade-retrograde cardioplegia
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | antegrade cardioplegia Receives: Procedure: retrograde cardioplegia protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial function
compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease Left MainStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- RCT
- 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, El hussein Mohamed Abdelmotaleb Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439162
- Sponsor's protocol ID
- coronary artery bypass surgery
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 19 Jun 2020
- 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 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Combined Antegrade and Retrograde Versurs Antegrade Cardioplegia in Complex Coronary Artery Bypass Surgeries
- ClinicalTrials.gov ID
- NCT04439162
- Acronym / sponsor ID
- coronary artery bypass surgery
- Conditions
- Coronary Artery Disease Left Main
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 19 Jun 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.
During coronary artery bypass surgery, myocardial protection, especially of the right ventricle, may be inadequate in the presence of severe coronary lesions that obstruct the antegrade delivery of cold cardioplegia
Detailed description
Asymetric myocardial cooling has been reported to yield postoperative right ventricular dysfunction, which may contribute to postoperative morbidity and mortality. Retrograde coronary sinus perfusion was introduced in 1956 to facilitate surgery involving the aortic valve. This technique was introduced as a means of myocardial protection for coronary artery bypass surgery in 1967 and has recently received renewed interest. An innovative method of delivering retrograde cardioplegia through the right atrium was recently developed by Fabiani and associates. This technique has obviated the need to directly cannulate the coronary sinus and thus has eliminated concerns regarding coronary sinus rupture due to cannulation, and concerns of inadequate right ventricular perfusion. In contrast to antegrade delivery, retrograde delivery of cardioplegia through the right atrium is not subject to the problem of limited distribution in the presence of coronary artery occlusive disease and thus allows more uniform cooling of the left ventricle,so the study will compare the results of combined antegrade and retrograde versurs antegrade cardioplegia in complex coronary artery bypass surgeries
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: retrograde cardioplegia protectionantegrade cardioplegia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years
- LV ejection fraction between 30 and 50%
- left main stem CAD
- mitral or aortic valve disease associated with ischemic heart disease
Key exclusion criteria (5 listed)
- Double valve disease or other valve disease
- mitral or aortic valve disease associated with congenital heart disease
- patients subjected to prior heart surgery
- emergency operation
- poorly controlled diabetes mellitus
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 |
|---|---|---|
| retrograde cardioplegia protectionantegrade-retrograde cardioplegia | Procedure or surgery | group A |
Primary outcome
myocardial function
Time frame: two years
compare simultaneous antegrade-retrograde cardioplegia with antegrade cardioplegia in coronary artery surgeries in preservation of myocardial function by using transthoracic echocardiography examination postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde cardioplegia protection in people with Coronary Artery Disease Left Main, run by Assiut University.
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 4 inclusion and 5 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 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Elhussein M abdelmottaleb, Ph.D (00201003873076, sahs_romeo90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial function (time frame: two years). 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 19 Jun 2020.