Measuring heart microvascular function in heart attack patients

ConMicro STEMI: Assessment of Coronary Microvascular Dysfunction After ST-Elevation Myocardial Infarction Using Continuous Saline Thermodilution

This study is testing how well the tiny blood vessels in the heart work in people who have had a heart attack to see how treatment affects their recovery.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06795035 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the heart's microvascular function in patients experiencing a heart attack, specifically ST-elevation myocardial infarction (STEMI). Using a technique called continuous saline thermodilution (CST), the study will evaluate coronary blood flow and microvascular resistance after patients receive balloon and/or stent therapy. Participants will undergo CST measurements during their treatment and follow-up MRI scans to determine the extent of heart muscle injury and recovery. The study seeks to provide insights into the microvascular dysfunction that occurs during a myocardial infarction.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who present to the Cleveland Clinic within 24 hours of STEMI symptoms and are undergoing emergent primary PCI.

Not a fit: Patients with no evidence of coronary obstruction or those in hemodynamic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of heart attacks, potentially enhancing recovery outcomes for patients.

How similar studies have performed: While the approach of assessing microvascular function is established, this specific application of CST in acute STEMI patients is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Khaled Ziada, MD — The Cleveland Clinic
• Study coordinator: Khaled Ziada, MD

Conditions: ST Elevation Myocardial Infarction, Coronary Microvascular Dysfunction, Microvascular Obstruction, STEMI, Microvascular, MVO, MRR, Thermodilution