Actively Recruiting
Assessment of Coronary Microvascular Dysfunction After ST-Elevation Myocardial Infarction Using Continuous Saline Thermodilution
Led by The Cleveland Clinic · Updated on 2025-07-31
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating heart microvascular function in people who have experienced a heart attack called ST-elevation myocardial infarction (STEMI). The study focuses on measuring this function using a method called continuous saline thermodilution (CST) after emergency treatment to open blocked arteries. The main goals are to understand the CST measurements during treated heart attacks and to see if these can predict heart muscle injury and recovery. Participants receive emergency balloon and/or stent therapy to open blocked coronary arteries. After this treatment, their heart's microvascular system is tested using CST, a technique that measures blood flow and resistance in small heart vessels without using active medication, only saline. Several days later, participants undergo a heart MRI to assess injury. This observational study follows patients presenting within 24 hours of symptom onset and treated at a cardiac catheterization lab. During the study, participants have clinic visits with medical history updates, physical exams, and echocardiograms to track heart function over time. Researchers monitor outcomes like microvascular resistance reserve (MRR) at enrollment, changes in heart wall movement and ejection fraction over three months, and presence of microvascular obstruction shortly after hospital discharge. They also observe clinical events such as mortality, heart failure, and anginal symptoms through follow-up. Participation lasts from initial emergency treatment through routine follow-up visits.
CONDITIONS
Brief Title
Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old presenting within 24 hours of symptom onset with clinical and EKG findings of STEMI
- Adults over 18 years old undergoing pharmaco-invasive management of failed fibrinolysis with intent for emergent PCI
- Culprit artery identified on diagnostic angiography
- Treating cardiologist trained in continuous saline thermodilution method
- Ability to provide initial oral consent and written consent after cardiac catheterization
You will not qualify if you...
- No coronary obstruction found on diagnostic angiography
- Patients in hemodynamic shock
- Culprit artery less than 3.0 mm in diameter
- Culprit artery is a bypass graft
- Unable to tolerate extra time for coronary microvascular testing after PCI
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 for cardiac MRI data contribution
- Standard contraindications to cardiac MRI (e.g., pacemakers, cochlear implants, certain prosthetic heart valves, surgical implants)
- Unable to provide verbal and written consent
- Pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Less than 1 day
Participants undergo coronary catheterization and continuous saline thermodilution testing to assess coronary microvascular function immediately following primary PCI for STEMI.
1 visit (in-person during emergent PCI)
Duration - Up to 3 months
Participants attend clinic visits for medical history updates, physical exams, echocardiography, and monitoring of clinical outcomes such as heart failure, angina, and major adverse cardiac events.
Approximately 2 clinic visits (including echocardiography at 1 day and 3 months post-PCI)
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
K
Khaled Ziada, MD
V
Vincent Chen, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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