Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03479593
Status:
RECRUITING
Last Update Posted:
2023-03-29
First Post:
2017-11-27
Brief Title:
Culprit Lesions in NSTEMI With Multi Vessel Disease NSTEMI-CULPRIT
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease
Status:
RECRUITING
Status Verified Date:
2023-03
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:
NS-CULPRIT
Brief Summary:
Acute myocardial infarction owes to a plaque rupture resulting in total STEMI or partial occlusion NSTEMI of the coronary artery In patients with a partial occlusion and multi vessel disease MVD identification of the lesion responsible for the current event culprit at the time of the examination coronary angiogram CAG can be difficult
Meanwhile identification of the culprit lesion is vital to conduct proper treatment Furthermore treating an artery with no plaque rupture non-culprit imposes a small risk for complications which may be fatal Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD
Meanwhile identification of the culprit lesion is vital to conduct proper treatment Furthermore treating an artery with no plaque rupture non-culprit imposes a small risk for complications which may be fatal Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD
Detailed Description:
Background
Acute myocardial infarction owes to a plaque rupture resulting in total STEMI or partial occlusion NSTEMI of the coronary artery Current guidelines in NSTEMI recommend an invasive coronary angiogram CAG and possible treatment with percutaneous intervention PCI within 2-72 hours In NSTEMI patients and multi vessel disease MVD identification of the lesion responsible for the current event culprit at the time of the examination can be difficult
Meanwhile identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium Furthermore treating an artery with no plaque rupture non-culprit imposes a small risk for complications which may be fatal In addition since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
Purpose
The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD
Methods
The study employs cardiac magnetic resonance CMR which allows detection of myocardium exposed to even brief periods of ischemia Furthermore Optical Coherence Tomography OCT which visualises the coronary artery lumen and wall OCT allows for direct visualization of atherosclerotic plaques presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone
Patients will have CMR performed prior to CAG The PCI operator determines culprit based on CAG and ECG changes alone OCT is subsequently performed on culprit lesions and stenosis 50
Sample size calculation
Assuming the culprit lesion can be correctly identified with historyangiographyECG in 95 of cases a positive predictive value 90 with 95 accuracy can be reached with 100 patients
Acute myocardial infarction owes to a plaque rupture resulting in total STEMI or partial occlusion NSTEMI of the coronary artery Current guidelines in NSTEMI recommend an invasive coronary angiogram CAG and possible treatment with percutaneous intervention PCI within 2-72 hours In NSTEMI patients and multi vessel disease MVD identification of the lesion responsible for the current event culprit at the time of the examination can be difficult
Meanwhile identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium Furthermore treating an artery with no plaque rupture non-culprit imposes a small risk for complications which may be fatal In addition since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
Purpose
The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD
Methods
The study employs cardiac magnetic resonance CMR which allows detection of myocardium exposed to even brief periods of ischemia Furthermore Optical Coherence Tomography OCT which visualises the coronary artery lumen and wall OCT allows for direct visualization of atherosclerotic plaques presence of thrombus and atherosclerotic plaque ruptured that cannot be seen on a CAG alone
Patients will have CMR performed prior to CAG The PCI operator determines culprit based on CAG and ECG changes alone OCT is subsequently performed on culprit lesions and stenosis 50
Sample size calculation
Assuming the culprit lesion can be correctly identified with historyangiographyECG in 95 of cases a positive predictive value 90 with 95 accuracy can be reached with 100 patients
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