CADNCT06173609
Long LIMA Patch on Left Anterior Descending Coronary Artery in CABG
An observational study of CAD and LIMA, run by Assiut University.
Trial summary
To assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes Read more about this study
- Who is it for?
- Ages 30 to 90 years
- What is being tested?
- CABG
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- How long will I take part?
- 6 Months
- 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 30 to 90 years
- All sexes
- Adult, Older adult
Study population: Perioperative data values were coded, processed and collected in tables. Qualitative data were described using number and percent. Quantitative data were described using median and standard deviation. Statistical significance was assumed if a p value of 0.05 or less was achieved.
Who may be able to join
- Any patient male,( or female) and his(or her) age from 30-90 years have Ischemic Heart Disease for CABG with diffusely diseased LAD.
Who cannot join
- Any patient performed open heart surgery before
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long Left Internal Mammary Artery Patch on Left Anterior Descending Coronary Artery in Coronary Artery Bypass Grafting
To assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes
Read the detailed description
It is well-known that coronary artery bypass graft (CABG) surgery significantly increases life expectancy, so complete myocardial revascularization should be the main goal of the surgical intervention process (1). During coronary artery bypass surgery, the surgeon removes a piece of blood vessel from the leg, chest, arm, or belly. Then, the surgeon uses that piece of blood vessel (called a "graft") to reroute blood around the blocked artery. The surgery is called "bypass surgery" because it bypasses the blockage Complete revascularization in CABG is crucial to improve early and late outcomes after surgery. Conventional procedures cannot achieve satisfactory results in severely diseased left anterior descending coronary artery .
Endarterectomy for severely atherosclerotic coronary artery disease (CAD) has a higher surgical risk and poor late outcomes . Reconstruction of diffusely diseased LAD with left internal mammary artery (LIMA) on-lay patch has less risk and complications than endarterectomy technique Ogus and colleagues used LIMA on-lay patches for the reconstruction of LAD based on the superior patency rate of the LIMA over other techniques which are more time-consuming. According to Lüscher and colleagues , the advantage of LIMA on-lay patch is to provide better vasomotor function and adjust the flow rate in proportion to the distal runoff.
In the recent study by Rezk etal., reported that , LAD reconstruction with a LIMA patch could have a better short-term outcome than other techniques as saphenous vein patch without an endarterectomy for a diffusely diseased left anterior descending coronary artery.
- Being tested
- CABG
- Keywords
- CABG, LIMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABGProcedure or surgery
During coronary artery bypass surgery, the surgeon removes a piece of blood vessel from the leg, chest, arm, or belly. Then, the surgeon uses that piece of blood vessel (called a "graft") to reroute blood around the blocked artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes
asses postoperative new arrhythmia//use of Inotropes// second session of surgery
Measured: first week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CADStudies 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Ahmed Mohamed, Assiut University
- Investigators
- Sameh Abdelrahman, professor, Study chair, Professor of Cardiothoracic surgeryAhmed Mohamed Taha, professor, Principal investigator, Professor of Cardiothoracic surgeryMohammed Hasan Osman, professor, Study director, Professor of General surgery Maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173609
- Sponsor's protocol ID
- Long LIMA patch in CABG
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Todorov IP, Todorova ZP, Nikolov DP. Angioplasty balloon occlusion of LIMA graft in reoperations of patients with prosthetic valve endocarditis and patent LIMA-LAD graft. Kardiochir Torakochirurgia Pol. 2022 Dec;19(4):199-204. doi: 10.5114/kitp.2022.122089. Epub 2022 Dec 24.
PubMed 36643344Yang T, Yuan X, Li B, Zhao S, Sun H, Lu M. Long-term outcomes after coronary artery bypass graft with or without surgical ventricular reconstruction in patients with severe left ventricular dysfunction. J Thorac Dis. 2023 Apr 28;15(4):1627-1639. doi: 10.21037/jtd-22-1214. Epub 2023 Mar 23.
PubMed 37197557
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Left Internal Mammary Artery Patch on Left Anterior Descending Coronary Artery in Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06173609
- Acronym / sponsor ID
- Long LIMA patch in CABG
- Keywords
- CABG, LIMA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Dec 2023 (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.
To assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes
Detailed description
It is well-known that coronary artery bypass graft (CABG) surgery significantly increases life expectancy, so complete myocardial revascularization should be the main goal of the surgical intervention process (1). During coronary artery bypass surgery, the surgeon removes a piece of blood vessel from the leg, chest, arm, or belly. Then, the surgeon uses that piece of blood vessel (called a "graft") to reroute blood around the blocked artery. The surgery is called "bypass surgery" because it bypasses the blockage Complete revascularization in CABG is crucial to improve early and late outcomes after surgery. Conventional procedures cannot achieve satisfactory results in severely diseased left anterior descending coronary artery .
Endarterectomy for severely atherosclerotic coronary artery disease (CAD) has a higher surgical risk and poor late outcomes . Reconstruction of diffusely diseased LAD with left internal mammary artery (LIMA) on-lay patch has less risk and complications than endarterectomy technique Ogus and colleagues used LIMA on-lay patches for the reconstruction of LAD based on the superior patency rate of the LIMA over other techniques which are more time-consuming. According to Lüscher and colleagues , the advantage of LIMA on-lay patch is to provide better vasomotor function and adjust the flow rate in proportion to the distal runoff.
In the recent study by Rezk etal., reported that , LAD reconstruction with a LIMA patch could have a better short-term outcome than other techniques as saphenous vein patch without an endarterectomy for a diffusely diseased left anterior descending coronary artery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Perioperative data values were coded, processed and collected in tables. Qualitative data were described using number and percent. Quantitative data were described using median and standard deviation. Statistical significance was assumed if a p value of 0.05 or less was achieved.
Key inclusion criteria (1 listed)
- Any patient male,( or female) and his(or her) age from 30-90 years have Ischemic Heart Disease for CABG with diffusely diseased LAD.
Key exclusion criteria (1 listed)
- Any patient performed open heart surgery before
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 |
|---|---|---|
| CABGDuring coronary artery bypass surgery, the surgeon removes a piece of blood vessel from the leg, chest, arm, or belly. Then, the surgeon uses that piece of blood vessel (called a "graft") to reroute blood around the blocked artery. | Procedure or surgery | – |
Primary outcome
assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes
Time frame: first week postoperative
asses postoperative new arrhythmia//use of Inotropes// second session of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 36643344Todorov IP, Todorova ZP, Nikolov DP. Angioplasty balloon occlusion of LIMA graft in reoperations of patients with prosthetic valve endocarditis and patent LIMA-LAD graft. Kardiochir Torakochirurgia Pol. 2022 Dec;19(4):199-204. doi: 10.5114/kitp.2022.122089. Epub 2022 Dec 24.
- Background: PubMed 37197557Yang T, Yuan X, Li B, Zhao S, Sun H, Lu M. Long-term outcomes after coronary artery bypass graft with or without surgical ventricular reconstruction in patients with severe left ventricular dysfunction. J Thorac Dis. 2023 Apr 28;15(4):1627-1639. doi: 10.21037/jtd-22-1214. Epub 2023 Mar 23.
Related trials for CAD
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
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.
Sameh Abdelrahman, professor study chair
Professor of Cardiothoracic surgery
Ahmed Mohamed Taha, professor principal investigator
Professor of Cardiothoracic surgery
Mohammed Hasan Osman, professor study director
Professor of General surgery Maxillofacial surgery
Questions about this trial
What is this clinical trial studying?
An observational study of CAD and LIMA, 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 15 Dec 2023. 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 Marwan Ahmed Mohamed, resident doctor (01282636415, marwanahmed1997y2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the effect of LIMA patch as a method for the reconstruction on diffusely diseased LAD in the early and midterm outcomes (time frame: first week postoperative). 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 NCT06173609, which also lists 2 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 15 Dec 2023.