Left Main Coronary Artery Disease With Acute Coronary SyndromeNCT06328322
Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals
An observational study of Left Main Coronary Artery Disease With Acute Coronary Syndrome, run by Sohag University at 1 site in Egypt.
Trial summary
Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Main Coronary Artery Disease With Acute Coronary Syndrome
- What is being tested?
- Percutaneous Coronary Intervention in Left Main Artery Disease
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Age > 18 years. * Acute coronary syndromes (ACS). * Left main coronary artery disease (LMCAD) on CA.
Who may be able to join
- Age > 18 years.
- Acute coronary syndromes (ACS).
- Left main coronary artery disease (LMCAD) on CA.
Who cannot join
- Patients with contraindications to coronary angiography or invasive procedures.
- Prior history of percutaneous coronary intervention (PCI) with left main stenting.
- Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
- Pregnancy or lactation.
- Refusal to participate
- Contra indication to antiplatelet.
Trial locations and contacts
1 site in 1 country.
Ali A Mahmoud Ahamed Kassem, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomes
The left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategies
Read more
Among the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral walls
The selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process
- Being tested
- Percutaneous Coronary Intervention in Left Main Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention in Left Main Artery DiseaseProcedure or surgery
To investigate and assess the effectiveness and safety of percutaneous coronary intervention in left main coronary artery disease in sitting of acute coronary syndromes.
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events (MACE)
cardiovascular death, myocardial infarction, repeat revascularization, and stroke
Measured: 6 months post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Left Main Coronary Artery Disease With Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Bahaa Eldeen Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328322
- Sponsor's protocol ID
- Soh-Med-24-03-02MD
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dabrowski EJ, Kozuch M, Dobrzycki S. Left Main Coronary Artery Disease-Current Management and Future Perspectives. J Clin Med. 2022 Sep 28;11(19):5745. doi: 10.3390/jcm11195745.
PubMed 36233613Waterbury TM, Tarantini G, Vogel B, Mehran R, Gersh BJ, Gulati R. Non-atherosclerotic causes of acute coronary syndromes. Nat Rev Cardiol. 2020 Apr;17(4):229-241. doi: 10.1038/s41569-019-0273-3. Epub 2019 Oct 3.
PubMed 31582839Spadaccio C, Benedetto U. Coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in the treatment of multivessel coronary disease: quo vadis? -a review of the evidences on coronary artery disease. Ann Cardiothorac Surg. 2018 Jul;7(4):506-515. doi: 10.21037/acs.2018.05.17.
PubMed 30094215
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Percutaneous Coronary Intervention in Left Main Coronary Artery Disease in Patients With Acute Coronary Syndrome at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06328322
- Acronym / sponsor ID
- Soh-Med-24-03-02MD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 25 Mar 2024 (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.
Acute coronary syndromes (ACS) encompass a spectrum of cardiovascular disorders characterized by the sudden onset of myocardial ischemia. They are primarily caused by atherosclerotic plaque rupture or erosion, leading to partial or complete occlusion of the coronary arteries. Among the various coronary arteries affected, left main coronary artery disease (LMCAD) is of particular concern due to its high anatomical significance and potential for adverse outcomes
The left main coronary artery (LMCA) is responsible for supplying a substantial portion of the left ventricular myocardium, including the interventricular septum and the anterior and lateral walls. Any obstruction or compromise in blood flow within this critical artery can have severe consequences, including myocardial infarction, heart failure, or even sudden cardiac death. The management of LMCAD associated with ACS represents a significant clinical challenge, necessitating prompt and optimal treatment strategies
Among the various coronary arteries affected by atherosclerosis, left main coronary artery disease (LMCAD) holds particular clinical significance due to its anatomical location and the vital role it plays in supplying a substantial portion of the left ventricular myocardium. The left main coronary artery (LMCA) typically bifurcates into the left anterior descending artery (LAD) and the left circumflex artery (LCX), which together provide blood supply to the majority of the left ventricle, including the interventricular septum and the anterior and lateral walls
The selection of an appropriate treatment strategy for LMCAD associated with ACS is a complex decision that requires careful consideration of multiple factors, including patient characteristics, coronary anatomy, severity of ischemia, and procedural expertise. The emergence of several clinical trials and observational studies exploring the efficacy and safety of different revascularization strategies has further complicated the decision-making process
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Age > 18 years. * Acute coronary syndromes (ACS). * Left main coronary artery disease (LMCAD) on CA.
Key inclusion criteria (3 listed)
- Age > 18 years.
- Acute coronary syndromes (ACS).
- Left main coronary artery disease (LMCAD) on CA.
Key exclusion criteria (7 listed)
- Patients with contraindications to coronary angiography or invasive procedures.
- Prior history of percutaneous coronary intervention (PCI) with left main stenting.
- Known allergy or intolerance to the medications or devices commonly used during PCI procedures.
- Severe comorbidities or conditions that may limit life expectancy or impact the ability to follow the study protocol.
- Pregnancy or lactation.
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 |
|---|---|---|
| Percutaneous Coronary Intervention in Left Main Artery DiseaseTo investigate and assess the effectiveness and safety of percutaneous coronary intervention in left main coronary artery disease in sitting of acute coronary syndromes. | Procedure or surgery | – |
Primary outcome
major adverse cardiac events (MACE)
Time frame: 6 months post PCI
cardiovascular death, myocardial infarction, repeat revascularization, and stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 36233613Dabrowski EJ, Kozuch M, Dobrzycki S. Left Main Coronary Artery Disease-Current Management and Future Perspectives. J Clin Med. 2022 Sep 28;11(19):5745. doi: 10.3390/jcm11195745.
- Background: PubMed 31582839Waterbury TM, Tarantini G, Vogel B, Mehran R, Gersh BJ, Gulati R. Non-atherosclerotic causes of acute coronary syndromes. Nat Rev Cardiol. 2020 Apr;17(4):229-241. doi: 10.1038/s41569-019-0273-3. Epub 2019 Oct 3.
- Background: PubMed 30094215Spadaccio C, Benedetto U. Coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) in the treatment of multivessel coronary disease: quo vadis? -a review of the evidences on coronary artery disease. Ann Cardiothorac Surg. 2018 Jul;7(4):506-515. doi: 10.21037/acs.2018.05.17.
Related trials for Left Main Coronary Artery Disease With Acute Coronary Syndrome
Recruiting
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
Multivessel Coronary Artery Disease, Acute Coronary Syndrome
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.
Ali A Mahmoud Ahamed Kassem, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Main Coronary Artery Disease With Acute Coronary Syndrome, run by Sohag 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 3 inclusion and 7 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 25 Mar 2024. 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?
Contact Mohammed M Bahaa Eldeen, assistant lecutrer (01023620185, mohamed.mohamed6@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (MACE) (time frame: 6 months post PCI). 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 NCT06328322, which also lists 3 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 25 Mar 2024.