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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Continuous Saline Thermodilution
Diagnostic testContinuous 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
Trial outcomes
Primary outcomes
Microvascular resistance reserve (MRR)
Calculated index to assess coronary microvascular dysfunction (Q\_hyperemia/Q\_rest)\*(Pa\_rest/Pd\_hyperemia)
Secondary outcomes
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)
Change in LVEF
Left ventricular ejection fraction as quantified by routine baseline echo to routine follow up echo
Presence of microvascular obstruction
Presence of microvascular obstruction on cardiac MRI
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
Abbott
Collaborator