Actively Recruiting

Age: 18Years +
All Genders
NCT06795035

Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

Led by The Cleveland Clinic · Updated on 2025-07-31

70

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

A

Abbott

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old presenting within 24 hours of symptom onset with clinical and EKG signs of STEMI, scheduled for emergency primary PCI with identified culprit artery
  • Adults over 18 years old presenting for pharmaco-invasive treatment after failed fibrinolysis, scheduled for emergency PCI with identified culprit artery
  • Treating interventional cardiologist trained in continuous saline thermodilution method for microvascular assessment
Not Eligible

You will not qualify if you...

  • No coronary obstruction found on diagnostic angiography (e.g., Takotsubo, myocarditis causing STEMI activation)
  • Patients in hemodynamic shock
  • Culprit artery smaller than 3.0 mm in diameter
  • Culprit artery is a bypass graft
  • Patients unable to tolerate additional time for microvascular testing after PCI
  • Patients with eGFR less than 30 mL/min/1.73m2 excluded from cardiac MRI
  • Patients with contraindications to cardiac MRI (e.g., pacemakers, cochlear implants, certain prosthetic heart valves or surgical implants) excluded from cardiac MRI
  • Unable to provide verbal and written consent
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

K

Khaled Ziada, MD

CONTACT

V

Vincent Chen, MD

CONTACT

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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