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Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

Study acronym: ConMICRO
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 50% 70 → 35 participants
See other at-risk trials from The Cleveland Clinic

Record History

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  1. Enrollment reduced: 70 → 35 participants
    • Eligibility criteria expanded, about 12 words
    • Study description revised
  2. Start date: Mar 25, 2025 to May 29, 2025
    • Study title shortened, about 3 words
    v3
  3. Lead sponsor: Khaled Ziada, MD to The Cleveland Clinicv2 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 31, 2026 to Dec 31, 2027
    • Start date changed from estimate of Mar 1, 2025 to Mar 25, 2025
    • Study description expanded, about 159 words
    • Site details revised
    • Collaborators: 2 to 1
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06795035
Lead Sponsor The Cleveland Clinic
Collaborators: Abbott
Conditions
(from sponsor)		 ST Elevation Myocardial Infarction, Coronary Microvascular Dysfunction, Microvascular Obstruction
Related terms ST Elevation Myocardial Infarction
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov