Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 11:59 AM
Study NCT ID:
NCT06795035
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microvascular resistance reserve (MRR)', 'timeFrame': 'At enrollment', 'description': 'Calculated index to assess coronary microvascular dysfunction (Q\\_hyperemia/Q\\_rest)\\*(Pa\\_rest/Pd\\_hyperemia)'}], 'secondaryOutcomes': [{'measure': 'Change in LV Wall Motion Summed Score', 'timeFrame': 'From 1-day echo to 3-month routine follow up echo', 'description': '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)'}, {'measure': 'Change in LVEF', 'timeFrame': 'From 1-day echo to 3-month routine follow up echo', 'description': 'Left ventricular ejection fraction as quantified by routine baseline echo to routine follow up echo'}, {'measure': 'Presence of microvascular obstruction', 'timeFrame': 'Within 3 days of hospital discharge', 'description': 'Presence of microvascular obstruction on cardiac MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STEMI', 'Microvascular', 'MVO', 'MRR', 'Thermodilution'], 'conditions': ['ST Elevation Myocardial Infarction', 'Coronary Microvascular Dysfunction', 'Microvascular Obstruction']}, 'descriptionModule': {'briefSummary': "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:\n\n* What measurements using CST can we expect from the heart's microvascular system during a treated MI?\n* Can CST measurements during a treated MI predict the amount of heart muscle that is injured and that recovers?\n\nFor 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.", 'detailedDescription': '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.\n\nAdult 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.\n\nStudy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n* On-call treating interventional cardiologist is trained in the method of continuous saline thermodilution for coronary microvascular assessment\n\nExclusion Criteria:\n\n* No evidence of coronary obstruction on diagnostic angiography (e.g., Takotsubo, myocarditis leading to STEMI activation).\n* Patients in hemodynamic shock\n* Culprit artery \\<3.0 mm in diameter.\n* Culprit artery being a bypass graft\n* Patients physically unable to tolerate additional time required to conduct coronary microvascular testing after primary PCI.\n* Patients with eGFR \\<30 mL/min/1.73m2 are excluded from contributing cardiac MRI data\n* 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\n* Unable to provide verbal and written consent\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06795035', 'acronym': 'ConMICRO STEMI', 'briefTitle': 'Assessment of Coronary Microvascular Dysfunction After STEMI Using Continuous Saline Thermodilution', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'ConMicro STEMI: Assessment of Coronary Microvascular Dysfunction After ST-Elevation Myocardial Infarction Using Continuous Saline Thermodilution', 'orgStudyIdInfo': {'id': '25-015'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous Saline Thermodilution', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vincent Chen, MD', 'role': 'CONTACT', 'email': 'CHENV3@ccf.org', 'phone': '440-226-1994'}, {'name': 'Khaled Ziada, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vincent Chen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Khaled Ziada, MD', 'role': 'CONTACT', 'email': 'ziadak@CCF.ORG', 'phone': '216-444-0926'}, {'name': 'Vincent Chen, MD', 'role': 'CONTACT', 'email': 'chenv3@ccf.org', 'phone': '440-226-1994'}], 'overallOfficials': [{'name': 'Khaled Ziada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Cardiologist', 'investigatorFullName': 'Khaled Ziada, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}