LMN DiseaseLIMACSNCT05701319
Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes
An observational study of LMN Disease, run by Assiut University at 3 sites in Egypt.
Trial summary
Limited data have been published on the management and outcome of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) that involves the left main (LM) coronary artery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- LMN Disease
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 3 sitesEgypt
- Study dates
- Feb 2023to Feb 2025
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with ACS and LM disease
Who may be able to join
- Consecutive adult patients admitted with ACS (diagnosed within 72 hours before hospitalization) undergoing revascularization will be screened and considered for inclusion in the study.
- Patients with ACS (MI or unstable angina) undergoing PCI that involves unprotected LM with a DES will be enrolled; either same-session (during index procedure, with culprit lesion PCI) or scheduled in-hospital (same hospitalization with index PCI).
Who cannot join
- cannot provide informed consent
- Un-able/willing to comply with the study requirements including follow up visits
- Life expectancy <1 year
- Contraindications to anti-platelet drugs
- Rescue PCI (PCI after failed thrombolytic therapy)
- Prior CABG (patent LIMA)
- Severe CKD (GFR<30 ml/min)
Trial locations and contacts
3 sites in 1 country.
Mohammad Abdelghani, lecturer contact
Egypt3 sites
Assiut University
Asyut, 71515
Salma Taha, Ass.Prof, 01003329108, esmaeil.salma@aun.edu.eg
Salma Taha, Ass.Prof
Alazhar university
Cairo
Mohammad Abdelghani, lecturer, m.abdelghani.nl@gmail.com
Mohammad Abdelghani, lecturer
Tanta University
Tanta
Osama Shoaib, lecturer
Osama Shoaib, lecturer
About this study
Official title: Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes The LIMACS Multicenter Registry
Limited data have been published on the management and outcome of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) that involves the left main (LM) coronary artery. Little is known about different strategies and techniques of percutaneous revascularization and long-term outcomes of these patients. Beside scarcity of data, most studies represent outmoded experience not reflecting contemporary advances in stent technologies, with the introduction of newer generation thinner strut drug eluting stents (DES), bioresorbable polymers, and faster re-endothelization properties promoting vascular healing and endothelial repair. These advances have significantly reduced the rate of ischemic (especially thrombotic) complications in different cohorts. Whether these advances would alter the outcome of PCI that involves the LM in patients with ACS is yet to be explored.
II. Objective
- To explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACS
- To explore short- and long-term outcomes of patients of ACS with LM intervention III. Study endpoints Primary endpoint Major adverse cardiovascular events (MACE) at one year; a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization* *With further extended yearly follow-up to 5 years Secondary endpoints
- All-cause death at one year* 2) Non-fatal MI at one year* 3) Any unplanned revascularization at one year* 4) Target vessel revascularization (TVR) at one year* 5) Academic Research Consortium (ARC) definite/probable stent thrombosis at one year* 6) Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at one year* 7) Contrast induced nephropathy (CIN) defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL within 72 hours after index PCI 8) Echocardiographic left ventricular ejection fraction (LVEF)% [Time Frame: from 6 to 12 months after index PCI]* 9) Angiographic (re)stenosis of the LM [Time Frame: from 6 to 12 months after index PCI] (Optional)
Read the detailed description
IV. Study Type Single-arm, prospective and retrospective, multicenter, open-label registry V. Study Population Consecutive adult patients admitted with ACS (diagnosed within 72 hours before hospitalization) undergoing revascularization will be screened and considered for inclusion in the study. Patients with ACS (MI or unstable angina) undergoing PCI that involves unprotected LM with a DES will be enrolled; either same-session (during index procedure, with culprit lesion PCI) or scheduled in-hospital (same hospitalization with index PCI).
Exclusion criteria:
- Cannot provide informed consent
- Un-able/willing to comply with the study requirements including follow up visits
- Life expectancy <1 year
- Contraindications to anti-platelet drugs
- Rescue PCI (PCI after failed thrombolytic therapy)
- Prior CABG (patent LIMA)
- Severe CKD (GFR<30 ml/min) VI. Study Treatment Eligible patients will receive ASA as per standard of care and ticagrelor/clopidogrel loading dose according to recent guidelines.
In patients with multivessel disease, treatment only of the culprit lesion/target vessel during index PCI is recommended. Clinical follow up (clinic visit/phone call) will be scheduled at 1, 6, 12, and 60 months. Control invasive coronary angiography at 6-12 months after index PCI will be encouraged. Echocardiographic evaluation of LVEF is recommended at 6 and 12 month-follow up.
VII. Study Duration Enrollment Duration: 24 months Follow up duration: Five years (predefined follow up scheduled at 1, 6, 12, and 60 months). Annual follow up between 12 and 60 months are encouraged but not mandated.
VIII. Estimated Enrollment 500 patients
Sample Size Calculation: As this is a single-arm registry, sample size calculation is not mandatory. However, a sample size of 450 subjects would be required according to the following assumptions:
Expected event rate: 3.0%, test significance level (alpha): 2.5% (1-sided), sample size: 400, power: 80%, expected drop out/protocol violation: 10%, final sample size: 450.
IX. Prespecified Subgroup Analyses
- One vs. two-stent LM-bifurcation technique
- LM culprit vs. non-culprit intervention
- Multivessel vs. single-vessel disease
- Complete vs. incomplete revascularization
- Diabetes mellitus (yes/no)
- STEMI: primary vs. scheduled pharmaco-invasive PCI X. Projected Study Timelines
- First patient enrollment: January 2023
- Last patient enrollment: December 2024
- First 12-month FUP: January 2024
- Last 12-month FUP: December 2025 (1ry endpoint completion)
- Final 5-year FUP: December 2028 (Study conclusion)
- Conditions
- LMN Disease
- Being tested
- PCI
- Keywords
- UPLM, ACS, PPCI
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
percutaneous coronary intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization*
Measured: one year
Secondary outcomes (3)
All-cause death
death due to any cause
Measured: one year
Non-fatal MI
Myocardial infarction
Measured: one year
Any unplanned revascularization
revascularization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LMN 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University, Al-Azhar University, Egyptian Soceity of Cardiology
- Responsible party
- Principal investigator, Salma Taha, Assiut University
- Investigators
- Osama Shoaib, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701319
- Sponsor's protocol ID
- LM in ACS
- Acronym
- LIMACS
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: through google drive
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes The LIMACS Multicenter Registry
- ClinicalTrials.gov ID
- NCT05701319
- Acronym / sponsor ID
- LIMACS / LM in ACS
- Conditions
- LMN Disease
- Keywords
- UPLM, ACS, PPCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Tanta University, Al-Azhar University, Egyptian Soceity of Cardiology
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Jan 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.
Limited data have been published on the management and outcome of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) that involves the left main (LM) coronary artery. Little is known about different strategies and techniques of percutaneous revascularization and long-term outcomes of these patients. Beside scarcity of data, most studies represent outmoded experience not reflecting contemporary advances in stent technologies, with the introduction of newer generation thinner strut drug eluting stents (DES), bioresorbable polymers, and faster re-endothelization properties promoting vascular healing and endothelial repair. These advances have significantly reduced the rate of ischemic (especially thrombotic) complications in different cohorts. Whether these advances would alter the outcome of PCI that involves the LM in patients with ACS is yet to be explored.
II. Objective
- To explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACS
- To explore short- and long-term outcomes of patients of ACS with LM intervention III. Study endpoints Primary endpoint Major adverse cardiovascular events (MACE) at one year; a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization* *With further extended yearly follow-up to 5 years Secondary endpoints
- All-cause death at one year* 2) Non-fatal MI at one year* 3) Any unplanned revascularization at one year* 4) Target vessel revascularization (TVR) at one year* 5) Academic Research Consortium (ARC) definite/probable stent thrombosis at one year* 6) Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at one year* 7) Contrast induced nephropathy (CIN) defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL within 72 hours after index PCI 8) Echocardiographic left ventricular ejection fraction (LVEF)% [Time Frame: from 6 to 12 months after index PCI]* 9) Angiographic (re)stenosis of the LM [Time Frame: from 6 to 12 months after index PCI] (Optional)
Detailed description
IV. Study Type Single-arm, prospective and retrospective, multicenter, open-label registry V. Study Population Consecutive adult patients admitted with ACS (diagnosed within 72 hours before hospitalization) undergoing revascularization will be screened and considered for inclusion in the study. Patients with ACS (MI or unstable angina) undergoing PCI that involves unprotected LM with a DES will be enrolled; either same-session (during index procedure, with culprit lesion PCI) or scheduled in-hospital (same hospitalization with index PCI).
Exclusion criteria:
- Cannot provide informed consent
- Un-able/willing to comply with the study requirements including follow up visits
- Life expectancy <1 year
- Contraindications to anti-platelet drugs
- Rescue PCI (PCI after failed thrombolytic therapy)
- Prior CABG (patent LIMA)
- Severe CKD (GFR<30 ml/min) VI. Study Treatment Eligible patients will receive ASA as per standard of care and ticagrelor/clopidogrel loading dose according to recent guidelines.
In patients with multivessel disease, treatment only of the culprit lesion/target vessel during index PCI is recommended. Clinical follow up (clinic visit/phone call) will be scheduled at 1, 6, 12, and 60 months. Control invasive coronary angiography at 6-12 months after index PCI will be encouraged. Echocardiographic evaluation of LVEF is recommended at 6 and 12 month-follow up.
VII. Study Duration Enrollment Duration: 24 months Follow up duration: Five years (predefined follow up scheduled at 1, 6, 12, and 60 months). Annual follow up between 12 and 60 months are encouraged but not mandated.
VIII. Estimated Enrollment 500 patients
Sample Size Calculation: As this is a single-arm registry, sample size calculation is not mandatory. However, a sample size of 450 subjects would be required according to the following assumptions:
Expected event rate: 3.0%, test significance level (alpha): 2.5% (1-sided), sample size: 400, power: 80%, expected drop out/protocol violation: 10%, final sample size: 450.
IX. Prespecified Subgroup Analyses
- One vs. two-stent LM-bifurcation technique
- LM culprit vs. non-culprit intervention
- Multivessel vs. single-vessel disease
- Complete vs. incomplete revascularization
- Diabetes mellitus (yes/no)
- STEMI: primary vs. scheduled pharmaco-invasive PCI X. Projected Study Timelines
- First patient enrollment: January 2023
- Last patient enrollment: December 2024
- First 12-month FUP: January 2024
- Last 12-month FUP: December 2025 (1ry endpoint completion)
- Final 5-year FUP: December 2028 (Study conclusion)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with ACS and LM disease
Key inclusion criteria (2 listed)
- Consecutive adult patients admitted with ACS (diagnosed within 72 hours before hospitalization) undergoing revascularization will be screened and considered for inclusion in the study.
- Patients with ACS (MI or unstable angina) undergoing PCI that involves unprotected LM with a DES will be enrolled; either same-session (during index procedure, with culprit lesion PCI) or scheduled in-hospital (same hospitalization with index PCI).
Key exclusion criteria (7 listed)
- cannot provide informed consent
- Un-able/willing to comply with the study requirements including follow up visits
- Life expectancy <1 year
- Contraindications to anti-platelet drugs
- Rescue PCI (PCI after failed thrombolytic therapy)
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 |
|---|---|---|
| PCIpercutaneous coronary intervention | Procedure or surgery | – |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: one year
a composite of all-cause mortality, non-fatal myocardial infarction (MI), or unplanned revascularization*
3 secondary outcomes
All-cause death
Time frame: one year
Non-fatal MI
Time frame: one year
Any unplanned revascularization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided. through google drive
Related trials for LMN Disease
Not yet recruiting
Dorsal Root Ganglion Stimulation After Lower Motor Neuron Damage
Spinal Cord Injuries, Lower Motor Neuron Disease
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.
Mohammad Abdelghani, lecturer contact
Osama Shoaib, lecturer principal investigator
Tanta University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LMN Disease, run by Assiut University at 3 sites 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 2 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 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Salma Taha, Ass.Prof (+201003329108, esmaeil.salma@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: one year). 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 23 Feb 2023.