Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Microvascular resistance reserve (MRR)

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

Time frame
At enrollment

Secondary outcomes

1

Change in LV Wall Motion Summed Score

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)

Time frame
From 1-day echo to 3-month routine follow up echo
2

Change in LVEF

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

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

Presence of microvascular obstruction

Presence of microvascular obstruction on cardiac MRI

Time frame
Within 3 days of hospital discharge

Other outcomes

Sponsors and contacts

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