Recruiting

Microvascular Function

Sponsor:

The Cleveland Clinic

Code:

NCT06795035

Conditions

ST Elevation Myocardial Infarction

Coronary Microvascular Dysfunction

Microvascular Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Saline Thermodilution

Study Details

Brief 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.

Conditions

ST Elevation Myocardial Infarction

Coronary Microvascular Dysfunction

Microvascular Obstruction

Study ID

NCT06795035

Start date

May 29, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Interventions

Continuous Saline Thermodilution

Continuous saline thermodilution for determination of microvascular resistance reserve (MRR) is a novel operator-independent method to assess coronary microvascular function. CST has been studied in the setting of angina with nonobstructive coronary arteries (ANOCA), but not in the setting of acute MI. In contrast, bolus thermodilution, used to determine the index of microcirculatory resistance (IMR), has been shown in the setting of STEMI to predict extent of myocardial injury and long-term clinical outcomes (e.g., heart failure, mortality, nonfatal MI, and ischemic stroke). In contrast to bolus thermodilution techniques, CST does not require the use of active medications (e.g., papaverine or adenosine) -- only a small volume of normal saline.

Primary outcome measure

  • Microvascular resistance reserve (MRR) [ Time Frame: At enrollment ]

Central Contacts and Locations

Central contacts

Khaled Ziada, MD

216-444-0926ziadak@CCF.ORG

Vincent Chen, MD

440-226-1994chenv3@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Vincent Chen, MD

440-226-1994CHENV3@ccf.org

Principal Investigator:

Khaled Ziada, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • STEMI
  • Microvascular
  • MVO
  • MRR
  • Thermodilution

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-07-31.