Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

Recruiting now

Conditions studied: ST Elevation Myocardial Infarction, Coronary Microvascular Dysfunction, Microvascular Obstruction

In brief

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.

Key facts

Study ID: NCT06795035
Run by: The Cleveland Clinic
People needed: 70
Starts: 2025-05-29
Expected to finish: 2027-12-31
Last updated by the study team: 2025-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults (persons >18 years old) presenting to Cleveland Clinic cardiac catheterization lab within 24 hours of symptom onset, with clinical and EKG findings concerning for STEMI, with intent to undergo emergent primary PCI, who have culprit artery identified on diagnostic angiography
Adults (persons >18 years old) presenting to Cleveland Clinic cardiac catheterization lab for pharmaco-invasive management of failed fibrinolysis, with intent to undergo emergent PCI, who have culprit artery identified on diagnostic angiography
On-call treating interventional cardiologist is trained in the method of continuous saline thermodilution for coronary microvascular assessment

You may not qualify if…

No evidence of coronary obstruction on diagnostic angiography (e.g., Takotsubo, myocarditis leading to STEMI activation).
Patients in hemodynamic shock
Culprit artery <3.0 mm in diameter.
Culprit artery being a bypass graft
Patients physically unable to tolerate additional time required to conduct coronary microvascular testing after primary PCI.
Patients with eGFR <30 mL/min/1.73m2 are excluded from contributing cardiac MRI data
Patients with standard contraindications to CMR (e.g., pacemakers, cochlear implants, certain prosthetic heart valves, certain surgical implants) are excluded from contributing cardiac MRI data
Unable to provide verbal and written consent
Pregnancy

Where it is running

Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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