Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-03 @ 2:41 PM
Study NCT ID:
NCT06529861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms Behind Microvascular Dysfunction in INOCA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-29', 'size': 539283, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-29T07:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for biobank: A blood sample will be collected for inclusion in a biobank for future research. As part of this process, a distinct patient information and consent form will be administered.\n\nAdipose biopsies are assessed in a laboratory at the Biomedical Institute, University of Copenhagen.\n\nFrom these biopsies, segments of small arteries will be promptly dissected free. One segment will be mounted in a myograph for recording of isometric tension (i.e., vasoconstriction and vasodilation) and for histochemical analysis, while the other segment will be snap-frozen for proteomic and histological analysis and the adipose tis-sue/perivascular adipose tissue will be used for genomic and transcriptomic analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tone of smooth muscle cells', 'timeFrame': 'Baseline only', 'description': 'Changes in isolated small artery reactivity assessed with myography'}, {'measure': 'Proteomic and transcriptomic analyses', 'timeFrame': 'Baseline only', 'description': 'Changes in gene and protein expressions patterns in small arteries'}], 'primaryOutcomes': [{'measure': 'Vascular function in response to acetylcholine stress', 'timeFrame': 'Baseline only', 'description': 'Vascular conductance measured by ultrasound doppler during infusion of acetylcholine'}], 'secondaryOutcomes': [{'measure': 'Vascular function in response to acetylcholine adenosine stress', 'timeFrame': 'Baseline only', 'description': 'Vascular conductance measured by ultrasound doppler during infusion of Adenosine'}, {'measure': 'Myocardial Blood flow reserve', 'timeFrame': 'Baseline only', 'description': 'Determined by the clinical assessment of \\[15O\\]H2O-PET'}, {'measure': 'Skeletal Muscle Microvascular Function', 'timeFrame': 'Baseline only', 'description': 'Evaluated by brachial artery ultrasound Doppler in response to exercise stress to measure blood flow responsiveness in skeletal muscles.'}, {'measure': 'Changes in isolated small artery reactivity assessed with myography', 'timeFrame': 'Baseline only', 'description': 'Analyzed using myograph to study the tone of smooth muscle cells'}, {'measure': 'Arterial Compliance', 'timeFrame': 'Baseline only', 'description': 'Determined by calculations made from intra-arterial pressure and arterial diameter measurements obtained via ultrasound Doppler to assess arterial compliance.'}, {'measure': 'Plasma Lipids', 'timeFrame': 'Baseline only', 'description': 'Conducted through clinical chemical analysis to measure levels of HDL, and triglycerides in the blood, providing insights into lipid profiles.'}, {'measure': 'Plasma HbA1c', 'timeFrame': 'Baseline only', 'description': 'Conducted through clinical chemical analysis to measure levels of HbA1c in the blood, providing insights into glucose metabolism.'}, {'measure': 'Plasma Levels of Markers Related to Vascular Function', 'timeFrame': 'Baseline only', 'description': 'Assessed using Mesoscale/ELISA to quantify biomarkers associated with vascular function'}, {'measure': 'Plasma Levels of Inflammatory Markers', 'timeFrame': 'Baseline only', 'description': 'Measured using Mesoscale/ELISA/O-Link platforms to evaluate the presence and levels of inflammatory markers'}, {'measure': 'Arterial Blood Pressure', 'timeFrame': 'Baseline only', 'description': 'Monitored with automated blood pressure measurements at rest and during exercise to assess overall cardiovascular health and response to physical activity.'}, {'measure': 'Cardiac Function', 'timeFrame': 'Baseline only', 'description': 'Changes in stroke volume using echocardiography during rest and exercise stress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Microvascular Dysfunction', 'Ischaemia With Non Obstructed Coronary Arteries']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify the causes of chest pain in patients experiencing chest pain with no signs of narrowing in the coronary arteries of the heart.', 'detailedDescription': 'A significant number of patients with ischemic heart disease do not exhibit coronary obstruction, leading to their symptoms being attributed to coronary microvascular dysfunction, a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying this microvascular dysfunction are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, an area yet to be explored.\n\nThis study aims to identify mechanisms underlying Coronary microvascular dysfunction (CMD) in angina and to assess whether exercise training can improve the condition. In study part I 30 patients with impaired coronary microvascular function and 30 asymptomatic controls will be studied to identify vascular and related molecular mechanisms underlying INOCA by investigating microvascular function in the heart and in cutaneous tissue, skeletal muscle, and adipose tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ischemia with no obstruction of coronary arteries (INOCA) is estimated to affect \\>150.000 Danes and the majority are females. These patients have a shorter life expectancy than age matched controls and a higher incidence of major cardiovascular events (1,2).\n\nINOCA is caused by microvascular dysfunction. When there is dysfunction in the microvascu-lature, the blood flow within the coronary vessels fails to increase adequately to meet the de-mand, resulting in ischemia and pain (angina).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOnly for angina patients: Have CMD, defined as myocardial bloodflow re-serve (MBFR) \\< 2.5 or hyperemic myocardial blood flow (hMBF) \\< 2.3ml/g/min\n\nExclusion Criteria:\n\n* Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile\n* Heart failure, defined as left ventricular ejection fraction of less than 40%\n* Uncontrolled hypertension defined as blood pressure above target 140/90 for all\n* Co-morbidity resulting in \\<1 year expected survival\n* Considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n* Unable or unwilling to exercise, e.g. due to arthritis or injury\\*\n* Already are regularly physically active and/or have a maximal oxygen uptake \\>45 ml/kg/min\n* The subject has a known allergy to either: norepinephrine, adenosine, ketorolac, and or ascorbic acid (vitamin C).'}, 'identificationModule': {'nctId': 'NCT06529861', 'acronym': 'ExINOCA-P1', 'briefTitle': 'Mechanisms Behind Microvascular Dysfunction in INOCA', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Identification of Mechanisms Behind Microvascular Dysfunction in Ischemia With No Obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'ExINOCA - Part I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ischemia and no obstructive coronary arteries', 'description': 'patients with angina and reduced myocardial blood flow reserve', 'interventionNames': ['Diagnostic Test: [15O]H2O-PET Imaging']}, {'label': 'Control', 'description': 'controls without angina', 'interventionNames': ['Diagnostic Test: [15O]H2O-PET Imaging']}], 'interventions': [{'name': '[15O]H2O-PET Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'This imaging technique will be used to measure myocardial blood flow (MBF) and myocardial blood flow reserve (MBFR) in patients. The PET-CT scan involves the use of the radioactive tracer \\[15O\\]H2O to visualize blood flow in the heart, providing crucial data on coronary microvascular function.', 'armGroupLabels': ['Control', 'Ischemia and no obstructive coronary arteries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Eva Prescott, MD, DMSc', 'role': 'CONTACT', 'email': 'Eva.Irene.Bossano.Prescott@regionh.dk', 'phone': '22572614'}, {'name': 'Mads Fischer, Ph.D.', 'role': 'CONTACT', 'email': 'mf@nexs.ku.dk', 'phone': '24485450'}], 'overallOfficials': [{'name': 'Ylva Hellsten, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Nutrition, Exercise and sports, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Clinical Professor', 'investigatorFullName': 'Eva Prescott', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}