Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05793567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'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'}, {'id': 'D000787', 'term': 'Angina Pectoris'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017023', 'term': 'Coronary Angiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D006334', 'term': 'Heart Function Tests'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary Flow Reserve (CFR)', 'timeFrame': 'Baseline', 'description': 'The CFR will be calculated as a ratio of coronary flow at peak hyperemia /coronary flow at rest.'}], 'secondaryOutcomes': [{'measure': 'Backward Compression Wave (BCW)', 'timeFrame': 'Baseline', 'description': 'The BCW is a measure of increased microvascular resistance during systole.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Coronary Microvascular Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to find out if patients with Type 2 Myocardial Infarction (T2MI) without significant epicardial coronary artery disease (CAD) have a greater chance of having coronary microvascular disease (CMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects receiving care at Mayo Clinic in Rochester, MN identified with T2MI and controls with atypical chest pain with indication for CMD testing will be enrolled in this study. Both groups will have no epicardial coronary stenosis \\>50% or obstructive disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to give informed consent\n* Structurally normal heart (normal LV and RV function, no more than mild valvular heart disease)\n* For controls: atypical chest pain with indication for CMD testing\n* For T2MI: meet criteria for T2MI according to the 4th Universal definition of MI (rise/fall of troponin with at least 1 value \\>99th centile+ evidence of symptoms or signs of myocardial ischemia)\n\nExclusion Criteria:\n\n* Acute coronary event (evidence of plaque rupture, fissure or dissection on coronary angiogram)\n* Known to have angiographically significant CAD/pressure wire positive for epicardial CAD\n* Inability to receive heparin products\n* Allergy/contraindication to acetylcholine/adenosine/nitroglycerine products\n* Prior coronary artery bypass grafting\n* Pregnancy (if sexually active woman of reproductive age, need negative pregnancy test prior to proceeding with coronary angiography - this is standard of care in cath lab)\n* Asthma with prior ICU admission due to bronchospasm/need for invasive ventilation'}, 'identificationModule': {'nctId': 'NCT05793567', 'briefTitle': 'A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessment of Microcirculatory Function in Type 2 Myocardial Infarction', 'orgStudyIdInfo': {'id': '22-012721'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T2MI Patients', 'description': 'Patients with T2MI and no epicardial coronary stenosis \\>50% will be prospectively enrolled and undergo a routine standard of care coronary angiogram with coronary reactivity testing (CRT).', 'interventionNames': ['Diagnostic Test: Coronary angiogram with coronary reactivity testing (CRT)']}, {'label': 'Controls', 'description': 'Patients with atypical chest pain and no obstructive disease on coronary angiogram who have been referred for investigation of suspected CMD and have a clinical indication for CMD testing will be retrospectively enrolled and data collected from a previous routine standard of care coronary angiogram with coronary reactivity testing (CRT) will be utilized.'}], 'interventions': [{'name': 'Coronary angiogram with coronary reactivity testing (CRT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'CRT is an angiography procedure (using X-ray) to examine the small blood vessels in the heart and how they respond to three drugs (adenosine, acetylcholine and nitroglycerin) as per clinical protocol.', 'armGroupLabels': ['T2MI Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'contacts': [{'name': 'Ischemic Heart Disease Research Team', 'role': 'CONTACT', 'phone': '507-255-1724'}, {'name': 'Claire Raphael, MBBS, PhD', 'role': 'CONTACT', 'email': 'Raphael.Claire@mayo.edu', 'phone': '507-255-2445'}, {'name': 'Claire Raphael, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Ischemic Heart Disease Research Team', 'role': 'CONTACT', 'phone': '507-255-1724'}, {'name': 'Claire Raphael, MBBS, PhD', 'role': 'CONTACT', 'email': 'Raphael.Claire@mayo.edu', 'phone': '507-255-2445'}], 'overallOfficials': [{'name': 'Claire Raphael, MBBS, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Claire E. Raphael', 'investigatorAffiliation': 'Mayo Clinic'}}}}