Coronary SyndromeNCT05300178
Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization
An observational study of Coronary Syndrome and Coronary Disease, run by Assiut University.
Trial summary
CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia . If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Coronary Syndrome, Coronary Disease, Coronary Artery Disease
- What is being tested?
- coronary artery bypass grafting surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2022to 22 Mar 2022
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with multi-coronary vessel disease who are indicated for CABG surgery .
Who may be able to join
- All patients with multi-coronary vessel disease eligible for CABG surgery .
Who cannot join
- 1. age more than 70 years 2. diabetic patient 3. single vessel disease 4. associated valvular disease 5. previous open heart surgery 6. hemodynamic unstability 7. Ejection fraction less than (40%)
Trial locations and contacts
No sites are listed yet.
About this study
CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia . If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results . Indications of this operation are more than 50% diameter stenosis of the left main coronary artery, more than 70% diameter stenosis in proximal left anterior descending artery (LAD), more than 70% diameter stenosis in three major coronary vessels, ventricular septal defect related to myocardial infarction , papillary muscle rupture , free wall rupture , ventricular pseudoaneurysm , life-threatening ventricular arrhythmias, and cardiogenic shock. Multiple methods have evolved to achieve the best outcome .The revascularization process depend on two main graft either artery or venous , each has its advantage and disadvantage according to their elasticity , ability to deliver an adequate flow and sustain high blood pressure. Our focus is on the different configuration used for the revascularization by using the artery grafts only due to the superiority of the artery graft in comparison to the venous according to the outcomes and not the feasibility of the technique .It is recommended to begin with internal thoracic artery then saphenous vein if both failed then multiple conduits will be used . Bilateral internal thoracic artery grafting can be an optimal option for coronary artery bypass grafting ,but it's the long-term outcome is still under study.There is no accepted configuration of the anastomosis to be used in the multiple conduits .
- Conditions
- Coronary Syndrome, Coronary Disease, Coronary Artery Disease
- Being tested
- coronary artery bypass grafting surgery
- Medical subject headings
- Angina, Unstable, Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary artery bypass grafting surgeryProcedure or surgery
Strategies of Complete Arterial Revascularization THE COMPOSITE TECHNIQUE When the distal RIMA bifurcation cannot loosely reach the LAD, we use the RIMA as a free graft, and a T-shaped , or if more suitable, a Y-shaped anastomosis at the level of the main pulmonary artery, is prepared before connection to cardiopulmonary bypass (CPB) THE CROSS TECHNIQUE The cross arrangement is based on the assumption that patency rates of the right internal mammary artery (RIMA) on the left anterior descending coronary artery (LAD) is similar to that of the left internal mammary artery (LIMA) on the LAD. To improve late survival, every effort should be made to use both IMA grafts for the left system THE IN SITU SEQUENCE When a graft to the posterior wall of the heart is not necessary (the circumflex region), the LIMA is grafted to the left anterior descending and the RIMA to the right coronary artery or its posterior de
| Study group | Role | What they receive |
|---|---|---|
| multiple vessel disease | patients with coronary artery disease will be revascularized by using different bypass configuration. Receives: Procedure: coronary artery bypass grafting surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective revascularization.
Measured: Changes Baseline perfustion after 3 months by MRI
Secondary outcomes (1)
Number of patient complicated by heart failure
Measured: changes in the base line heart rate after 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start22 Mar 2022 (estimated)
- Primary completion22 Mar 2022 (estimated)
- Study completion22 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed samir yussef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300178
- Sponsor's protocol ID
- coronary revascularization
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rocha EAV. Fifty Years of Coronary Artery Bypass Graft Surgery. Braz J Cardiovasc Surg. 2017 Jul-Aug;32(4):II-III. doi: 10.21470/1678-9741-2017-0104. No abstract available.
PubMed 28977193Garatti A, Castelvecchio S, Canziani A, Santoro T, Menicanti L. CABG in patients with left ventricular dysfunction: indications, techniques and outcomes. Indian J Thorac Cardiovasc Surg. 2018 Dec;34(Suppl 3):279-286. doi: 10.1007/s12055-018-0738-8. Epub 2018 Oct 17.
PubMed 33060950Amin S, Madsen PL, Werner RS, Krasopoulos G, Taggart DP. Intraoperative flow profiles of arterial and venous bypass grafts to the left coronary territory. Eur J Cardiothorac Surg. 2019 Jul 1;56(1):64-71. doi: 10.1093/ejcts/ezy473.
PubMed 30715312Kawajiri H, Grau JB, Fortier JH, Glineur D. Bilateral internal thoracic artery grafting: in situ or composite? Ann Cardiothorac Surg. 2018 Sep;7(5):673-680. doi: 10.21037/acs.2018.05.16.
PubMed 30505752Goldstone AB, Chiu P, Baiocchi M, Wang H, Lingala B, Boyd JH, Woo YJ. Second Arterial Versus Venous Conduits for Multivessel Coronary Artery Bypass Surgery in California. Circulation. 2018 Apr 17;137(16):1698-1707. doi: 10.1161/CIRCULATIONAHA.117.030959. Epub 2017 Dec 14.
PubMed 29242351
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization
- ClinicalTrials.gov ID
- NCT05300178
- Acronym / sponsor ID
- coronary revascularization
- Conditions
- Coronary Syndrome, Coronary Disease, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Mar 2022 (estimated)
- Primary completion
- 22 Mar 2022 (estimated)
- Study completion
- 22 Mar 2022 (estimated)
- First posted
- 29 Mar 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.
CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia . If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results . Indications of this operation are more than 50% diameter stenosis of the left main coronary artery, more than 70% diameter stenosis in proximal left anterior descending artery (LAD), more than 70% diameter stenosis in three major coronary vessels, ventricular septal defect related to myocardial infarction , papillary muscle rupture , free wall rupture , ventricular pseudoaneurysm , life-threatening ventricular arrhythmias, and cardiogenic shock. Multiple methods have evolved to achieve the best outcome .The revascularization process depend on two main graft either artery or venous , each has its advantage and disadvantage according to their elasticity , ability to deliver an adequate flow and sustain high blood pressure. Our focus is on the different configuration used for the revascularization by using the artery grafts only due to the superiority of the artery graft in comparison to the venous according to the outcomes and not the feasibility of the technique .It is recommended to begin with internal thoracic artery then saphenous vein if both failed then multiple conduits will be used . Bilateral internal thoracic artery grafting can be an optimal option for coronary artery bypass grafting ,but it's the long-term outcome is still under study.There is no accepted configuration of the anastomosis to be used in the multiple conduits .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiple vessel disease | – | Procedure: coronary artery bypass grafting surgerypatients with coronary artery disease will be revascularized by using different bypass configuration. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with multi-coronary vessel disease who are indicated for CABG surgery .
Key inclusion criteria (1 listed)
- All patients with multi-coronary vessel disease eligible for CABG surgery .
Key exclusion criteria (1 listed)
- 1. age more than 70 years 2. diabetic patient 3. single vessel disease 4. associated valvular disease 5. previous open heart surgery 6. hemodynamic unstability 7. Ejection fraction less than (40%)
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 grafting surgeryStrategies of Complete Arterial Revascularization THE COMPOSITE TECHNIQUE When the distal RIMA bifurcation cannot loosely reach the LAD, we use the RIMA as a free graft, and a T-shaped , or if more suitable, a Y-shaped anastomosis at the level of the main pulmonary artery, is prepared before connection to cardiopulmonary bypass (CPB) THE CROSS TECHNIQUE The cross arrangement is based on the assumption that patency rates of the right internal mammary artery (RIMA) on the left anterior descending coronary artery (LAD) is similar to that of the left internal mammary artery (LIMA) on the LAD. To improve late survival, every effort should be made to use both IMA grafts for the left system THE IN SITU SEQUENCE When a graft to the posterior wall of the heart is not necessary (the circumflex region), the LIMA is grafted to the left anterior descending and the RIMA to the right coronary artery or its posterior de | Procedure or surgery | multiple vessel disease |
Primary outcome
Effective revascularization.
Time frame: Changes Baseline perfustion after 3 months by MRI
1 secondary outcome
Number of patient complicated by heart failure
Time frame: changes in the base line heart rate after 24 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 28977193Rocha EAV. Fifty Years of Coronary Artery Bypass Graft Surgery. Braz J Cardiovasc Surg. 2017 Jul-Aug;32(4):II-III. doi: 10.21470/1678-9741-2017-0104. No abstract available.
- Background: PubMed 33060950Garatti A, Castelvecchio S, Canziani A, Santoro T, Menicanti L. CABG in patients with left ventricular dysfunction: indications, techniques and outcomes. Indian J Thorac Cardiovasc Surg. 2018 Dec;34(Suppl 3):279-286. doi: 10.1007/s12055-018-0738-8. Epub 2018 Oct 17.
- Background: PubMed 30715312Amin S, Madsen PL, Werner RS, Krasopoulos G, Taggart DP. Intraoperative flow profiles of arterial and venous bypass grafts to the left coronary territory. Eur J Cardiothorac Surg. 2019 Jul 1;56(1):64-71. doi: 10.1093/ejcts/ezy473.
- Background: PubMed 30505752Kawajiri H, Grau JB, Fortier JH, Glineur D. Bilateral internal thoracic artery grafting: in situ or composite? Ann Cardiothorac Surg. 2018 Sep;7(5):673-680. doi: 10.21037/acs.2018.05.16.
- Background: PubMed 29242351Goldstone AB, Chiu P, Baiocchi M, Wang H, Lingala B, Boyd JH, Woo YJ. Second Arterial Versus Venous Conduits for Multivessel Coronary Artery Bypass Surgery in California. Circulation. 2018 Apr 17;137(16):1698-1707. doi: 10.1161/CIRCULATIONAHA.117.030959. Epub 2017 Dec 14.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Coronary Syndrome and Coronary Disease, 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 1 inclusion and 1 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 29 Mar 2022. 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 ahmed s youssef, M.D (01002378685, drahmed.samir225@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective revascularization. (time frame: Changes Baseline perfustion after 3 months by MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05300178, which also lists 5 linked publications.
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 29 Mar 2022.