RECRUITING

A New Technique to Measure the Heart's Microvascular Function in Patients Experiencing Heart Attack

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Conditions

ST Elevation Myocardial InfarctionCoronary Microvascular DysfunctionMicrovascular ObstructionSTEMIMicrovascularMVOMRRThermodilution

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-25
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06795035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * On-call treating interventional cardiologist is trained in the method of continuous saline thermodilution for coronary microvascular assessment
  1. * No evidence of coronary obstruction on diagnostic angiography (e.g., Takotsubo, myocarditis leading to STEMI activation).
  2. * Patients in hemodynamic shock
  3. * Culprit artery \<3.0 mm in diameter.
  4. * Culprit artery being a bypass graft
  5. * Patients physically unable to tolerate additional time required to conduct coronary microvascular testing after primary PCI.
  6. * Patients with eGFR \<30 mL/min/1.73m2 are excluded from contributing cardiac MRI data
  7. * 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
  8. * Unable to provide verbal and written consent
  9. * Pregnancy

Contacts and Locations

Study Contact

Khaled Ziada, MD
CONTACT
216-444-0926
ziadak@CCF.ORG
Vincent Chen, MD
CONTACT
440-226-1994
chenv3@ccf.org

Principal Investigator

Khaled Ziada, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Khaled Ziada, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • STEMI
  • Microvascular
  • MVO
  • MRR
  • Thermodilution

Additional Relevant MeSH Terms

  • ST Elevation Myocardial Infarction
  • Coronary Microvascular Dysfunction
  • Microvascular Obstruction