Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

NCT06795035 | Recruiting

• 1 other identifier: 25-015
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

STEMI; Microvascular; MVO; MRR; Thermodilution

Outcome Measures

Primary Outcomes (1)

• Microvascular resistance reserve (MRR)

  Calculated index to assess coronary microvascular dysfunction (Q\_hyperemia/Q\_rest)\*(Pa\_rest/Pd\_hyperemia)

  At enrollment

Secondary Outcomes (3)

• Change in LV Wall Motion Summed Score

  From 1-day echo to 3-month routine follow up echo

• Change in LVEF

  From 1-day echo to 3-month routine follow up echo

• Presence of microvascular obstruction

  Within 3 days of hospital discharge

Interventions

Continuous Saline Thermodilution DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults presenting to catheterization lab within 24 hours of ischemic symptom onset with intent for emergent primary PCI due to STEMI on ECG or who have failed thrombolytic therapy and present for pharmaco-invasive management of STEMI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Abbott: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Khaled Ziada, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled Ziada, MD

CONTACT

216-444-0926; ziadak@CCF.ORG

Vincent Chen, MD

CONTACT

440-226-1994; chenv3@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 27, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)