Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06795035

Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Khaled Ziada, MD

PRINCIPAL_INVESTIGATOR

Vincent Chen, MD

CONTACT

[email protected]

440-226-1994

Vincent Chen, MD

SUB_INVESTIGATOR

About this study

This will be a non-interventional, prospective, descriptive analysis on a cohort of patients experiencing ST-elevation myocardial infarction (STEMI) who present to the Cleveland Clinic cardiac catheterization laboratory (CCL) for emergent primary percutaneous coronary intervention (PCI). The aim is to study acute coronary microvascular dysfunction using the method of continuous saline thermodilution to provide absolute measurements of coronary blood flow, coronary microvascular resistance, and microvascular resistance reserve (MRR) following primary PCI for STEMI patients.

Adult patients experiencing acute STEMI who present to the catheterization laboratory for emergent cardiac catheterization for STEMI, <24 hours after symptom onset, who undergo primary PCI to an IRA. Only those able to provide initial oral consent upon CCL presentation and confirmatory written consent following cardiac catheterization will be included in the study.

Study endpoints are part of usual standard practice, and include clinic visits with updated medical histories and physical examination, and echocardiography. Clinical endpoints of interest will include mortality, incident heart failure, anginal symptoms, and standard major adverse cardiac events including cardiac death, nonfatal MI, urgent coronary revascularization, or hospitalization for unstable angina.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Microvascular resistance reserve (MRR)

    Time frame: At enrollment

    Calculated index to assess coronary microvascular dysfunction (Q_hyperemia/Q_rest)*(Pa_rest/Pd_hyperemia)

Secondary outcomes

  1. Change in LV Wall Motion Summed Score

    Time frame: From 1-day echo to 3-month routine follow up echo

    Global wall motion abnormality score by echo based on 16 segment model (0= normal, 1=mild hypokinetic, 2= hypokinetic, 3= severely hypokinetic, 4= akinetic, 5= aneurysmal)

  2. Change in LVEF

    Time frame: From 1-day echo to 3-month routine follow up echo

    Left ventricular ejection fraction as quantified by routine baseline echo to routine follow up echo

  3. Presence of microvascular obstruction

    Time frame: Within 3 days of hospital discharge

    Presence of microvascular obstruction on cardiac MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled Ziada, MD

CONTACT

[email protected]

216-444-0926

Vincent Chen, MD

CONTACT

[email protected]

440-226-1994

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Abbott

Registry information

Official study title

ConMicro STEMI: Assessment of Coronary Microvascular Dysfunction After ST-Elevation Myocardial Infarction Using Continuous Saline Thermodilution

Acronym: ConMICRO STEMI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.