Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828681
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2021-03-30
Brief Title:
Angio-IMR and Cardiac MR-derived MVO in STEMI Patients
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Functional Coronary Angiography-Derived Index of Microcirculatory Resistance and Microvascular Obstruction in Cardiac Magnetic Resonance Imaging After ST-segment Elevation Myocardial Infarction
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction STEMI patients Microvascular obstruction MVO in cardiac magnetic resonance CMR is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention PCI Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO previous study presented that index of microcirculatory resistance IMR in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission Nevertheless the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice
Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or thermodilution method In this regard the current study will evaluate the feasibility of functional angiography-derived IMR angio-IMR in the evaluation of MVO after successful primary PCI for STEMI
Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or thermodilution method In this regard the current study will evaluate the feasibility of functional angiography-derived IMR angio-IMR in the evaluation of MVO after successful primary PCI for STEMI
Detailed Description:
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of ST-segment elevation myocardial infarction STEMI patients Microvascular obstruction MVO in cardiac magnetic resonance CMR is significant prognostic indicator in STEMI patients after primary percutaneous coronary intervention PCI Although current gold-standard method to assess microvascular damage or dysfunction in STEMI patients is CMR and assessment of MVO previous study presented that index of microcirculatory resistance IMR in culprit vessel of STEMI patients showed significant association with the presence of MVO in CMR and the risk of cardiac death or heart failure admission Nevertheless the need for pressure-temperature sensor wire and hyperemic agents significantly limits adoption of IMR in daily practice
Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or thermodilution method In this regard the current study will evaluate the feasibility of functional angiography-derived IMR angio-IMR in the evaluation of MVO after successful primary PCI for STEMI
The study population will be derived from the prospective institutional AMI registry of Samsung Medical Center between December 2007 and July 2014 Main results from this registry were published elsewhere PLoS One 2017 Jan 12121e0170115 and Sci Rep 2019 Jul 4919646 In this registry 515 consecutive patients who presented with acute myocardial infarction and underwent CMR were prospectively enrolled AMI was defined as evidence of myocardial injury defined as elevation of cardiac troponin values with at least one value above the 99th percentile upper reference limit with necrosis in a clinical setting consistent with myocardial ischemia Among the total patients STEMI patients n 332 whose electrocardiogram showed ST-segment elevation more than 1 mm in two or more contiguous leads or a presumably new-onset left bundle branch block will be analyzed for the current study For the study purpose patients with failed primary PCI n1 treated by medical treatment alone without PCI n4 and no available coronary angiographic images n3 will be excluded Among the remaining 324 patients functional coronary angiography core laboratory Shanghai Institute of Cardiovascular Diseases Shanghai China evaluated the quality of angiographic images and additionally exclude patients with insufficient image quality for angio-IMR calculation n37 All patients also underwent baseline and 1-year follow-up echocardiography The Institutional Review Board of Samsung Medical Center approved this study and all patients provided written informed consent
The association of Angio-IMR with CMR-derived quantitative parameters extent of MVO infarct size area at risk and qualitative parameter presence of MVO will be analyzed The discrimination ability of angio-IMR to predict the presence of MVO in CMR will be compared with conventional angiographic measures of culprit vessel reperfusion TIMI flow grade myocardial blush grade
Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or thermodilution method In this regard the current study will evaluate the feasibility of functional angiography-derived IMR angio-IMR in the evaluation of MVO after successful primary PCI for STEMI
The study population will be derived from the prospective institutional AMI registry of Samsung Medical Center between December 2007 and July 2014 Main results from this registry were published elsewhere PLoS One 2017 Jan 12121e0170115 and Sci Rep 2019 Jul 4919646 In this registry 515 consecutive patients who presented with acute myocardial infarction and underwent CMR were prospectively enrolled AMI was defined as evidence of myocardial injury defined as elevation of cardiac troponin values with at least one value above the 99th percentile upper reference limit with necrosis in a clinical setting consistent with myocardial ischemia Among the total patients STEMI patients n 332 whose electrocardiogram showed ST-segment elevation more than 1 mm in two or more contiguous leads or a presumably new-onset left bundle branch block will be analyzed for the current study For the study purpose patients with failed primary PCI n1 treated by medical treatment alone without PCI n4 and no available coronary angiographic images n3 will be excluded Among the remaining 324 patients functional coronary angiography core laboratory Shanghai Institute of Cardiovascular Diseases Shanghai China evaluated the quality of angiographic images and additionally exclude patients with insufficient image quality for angio-IMR calculation n37 All patients also underwent baseline and 1-year follow-up echocardiography The Institutional Review Board of Samsung Medical Center approved this study and all patients provided written informed consent
The association of Angio-IMR with CMR-derived quantitative parameters extent of MVO infarct size area at risk and qualitative parameter presence of MVO will be analyzed The discrimination ability of angio-IMR to predict the presence of MVO in CMR will be compared with conventional angiographic measures of culprit vessel reperfusion TIMI flow grade myocardial blush grade
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