Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05701319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-23
First Post:
2023-01-18
Brief Title:
Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Left Main Intervention in Myocardial Infarction and Acute Coronary Syndromes The LIMACS Multicenter Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMACS
Brief 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 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
1 To explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACS
2 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
1 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 definiteprobable 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 05 mgdL 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 restenosis of the LM Time Frame from 6 to 12 months after index PCI Optional
II Objective
1 To explore real-world PCI strategies and techniques in patients with unprotected LM coronary disease presenting with ACS
2 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
1 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 definiteprobable 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 05 mgdL 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 restenosis 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-ablewilling 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 GFR30 mlmin VI Study Treatment Eligible patients will receive ASA as per standard of care and ticagrelorclopidogrel loading dose according to recent guidelines
In patients with multivessel disease treatment only of the culprit lesiontarget vessel during index PCI is recommended Clinical follow up clinic visitphone 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 30 test significance level alpha 25 1-sided sample size 400 power 80 expected drop outprotocol violation 10 final sample size 450
IX Prespecified Subgroup Analyses
1 One vs two-stent LM-bifurcation technique
2 LM culprit vs non-culprit intervention
3 Multivessel vs single-vessel disease
4 Complete vs incomplete revascularization
5 Diabetes mellitus yesno
6 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
Exclusion criteria
Cannot provide informed consent
Un-ablewilling 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 GFR30 mlmin VI Study Treatment Eligible patients will receive ASA as per standard of care and ticagrelorclopidogrel loading dose according to recent guidelines
In patients with multivessel disease treatment only of the culprit lesiontarget vessel during index PCI is recommended Clinical follow up clinic visitphone 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 30 test significance level alpha 25 1-sided sample size 400 power 80 expected drop outprotocol violation 10 final sample size 450
IX Prespecified Subgroup Analyses
1 One vs two-stent LM-bifurcation technique
2 LM culprit vs non-culprit intervention
3 Multivessel vs single-vessel disease
4 Complete vs incomplete revascularization
5 Diabetes mellitus yesno
6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None