RecruitingNot Applicable

Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

United States70 participantsStarted 2025-05-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Microvascular resistance reserve (MRR)

Timeframe: At enrollment

Trial details

NCT IDNCT06795035

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Khaled Ziada, MD

216-444-0926 ziadak@CCF.ORG

View on ClinicalTrials.gov More ST Elevation Myocardial Infarction trials