Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 11:59 AM
Study NCT ID:
NCT06795035
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
ConMicro STEMI: Assessment of Coronary Microvascular Dysfunction After ST-Elevation Myocardial Infarction Using Continuous Saline Thermodilution
Status:
RECRUITING
Status Verified Date:
2025-07
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:
ConMICRO STEMI
Brief Summary:
The goal of this observational study to measure the heart's microvascular function in the setting of a myocardial infarction (MI), or heart attack, using a method called continuous saline thermodilution (CST). The participants will include people who are experiencing MI from sudden and complete blockage of a coronary artery requiring immediate balloon and/or stent therapy. After getting the balloon and/or stent therapy, participants will have their heart's microvascular system tested using CST. The main questions it aims to answer are:
* What measurements using CST can we expect from the heart's microvascular system during a treated MI?
* Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers?
For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.
* What measurements using CST can we expect from the heart's microvascular system during a treated MI?
* Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers?
For this study, participants will undergo measurement of their heart's microvascular function after balloon and/or stent therapy for the MI. They will then receive an MRI scan of the heart several days after the MI.
Detailed Description:
This will be a non-interventional, prospective, descriptive analysis on a cohort of patients experiencing ST-elevation myocardial infarction (STEMI) who present to the Cleveland Clinic cardiac catheterization laboratory (CCL) for emergent primary percutaneous coronary intervention (PCI). The aim is to study acute coronary microvascular dysfunction using the method of continuous saline thermodilution to provide absolute measurements of coronary blood flow, coronary microvascular resistance, and microvascular resistance reserve (MRR) following primary PCI for STEMI patients.
Adult patients experiencing acute STEMI who present to the catheterization laboratory for emergent cardiac catheterization for STEMI, \<24 hours after symptom onset, who undergo primary PCI to an IRA. Only those able to provide initial oral consent upon CCL presentation and confirmatory written consent following cardiac catheterization will be included in the study.
Study endpoints are part of usual standard practice, and include clinic visits with updated medical histories and physical examination, and echocardiography. Clinical endpoints of interest will include mortality, incident heart failure, anginal symptoms, and standard major adverse cardiac events including cardiac death, nonfatal MI, urgent coronary revascularization, or hospitalization for unstable angina.
Adult patients experiencing acute STEMI who present to the catheterization laboratory for emergent cardiac catheterization for STEMI, \<24 hours after symptom onset, who undergo primary PCI to an IRA. Only those able to provide initial oral consent upon CCL presentation and confirmatory written consent following cardiac catheterization will be included in the study.
Study endpoints are part of usual standard practice, and include clinic visits with updated medical histories and physical examination, and echocardiography. Clinical endpoints of interest will include mortality, incident heart failure, anginal symptoms, and standard major adverse cardiac events including cardiac death, nonfatal MI, urgent coronary revascularization, or hospitalization for unstable angina.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: