Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628377
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2020-11-08
Brief Title:
Prognostic Implication of Angiography-Derived IMR in STEMI Patients
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Prognostic Implication of Angiography-Derived Index of Microcirculatory Resistance in Successfully Reperfused STEMI Patients
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients Previous study presented that index of microcirculatory resistance IMR in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or theromdilution method In this regard the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized
Detailed Description:
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients Previous study presented that index of microcirculatory resistance IMR in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission Recent technical development enabled angiographic derivation of IMR without pressure wire hyperemic agents or theromdilution method In this regard the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized
The study cohorts consist with 2 separate cohort first diagnostic accuracy cohort which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR For this 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated The patients cohort is the subgroup of previous registry NCT02186093 Second prognosis cohort in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization Those patients have follow-up data after 10 years from index procedure This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center whose results were previously published JACC Cardiovascular Intervention 2019 Apr 8127607-620 Among 490 STEMI patients from the overall study cohorts 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed Primary clinical outcome will be cardiac death at 10 years from index procedure Secondary outcome will be any myocardial infarction ischemia-driven revascularization definite or probable stent thrombosis congestive heart failure admission at 10 years from index procedure
The study cohorts consist with 2 separate cohort first diagnostic accuracy cohort which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR For this 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated The patients cohort is the subgroup of previous registry NCT02186093 Second prognosis cohort in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization Those patients have follow-up data after 10 years from index procedure This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center whose results were previously published JACC Cardiovascular Intervention 2019 Apr 8127607-620 Among 490 STEMI patients from the overall study cohorts 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed Primary clinical outcome will be cardiac death at 10 years from index procedure Secondary outcome will be any myocardial infarction ischemia-driven revascularization definite or probable stent thrombosis congestive heart failure admission at 10 years from index procedure
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