[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639304":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":53,"studyPopulation":45,"armGroups":54,"interventions":62,"overallOfficials":45,"centralContacts":73,"locations":84,"responsibleParty":102,"collaborators":45,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":45,"studyType":120,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":133,"whyStopped":45,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Hospital de Clínicas Dr. Manuel Quintela","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7","Change in Seattle Angina Questionnaire-7 score from baseline to 12-month follow-up after invasive coronary phenotyping and phenotype-guided multidisciplinary treatment. The Seattle Angina Questionnaire-7 is a 7-item patient-reported outcome measure assessing angina-related health status. Scores range from 0 to 100, with higher scores indicating better angina-related health status and fewer symptoms.","Baseline to 12 months",[14,17,20,24,27,31,35,38,42],{"measure":15,"description":16,"timeFrame":12},"Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale","Change in EuroQol 5-Dimension 5-Level Visual Analog Scale score from baseline to 12-month follow-up. The EuroQol 5-Dimension 5-Level Visual Analog Scale is a patient-reported measure of overall health status. Scores range from 0 to 100, with higher scores indicating better self-reported health.",{"measure":18,"description":19,"timeFrame":12},"Change in Functional Capacity","Change in functional capacity assessed by six-minute walk test distance or exercise testing parameters, according to the local study protocol.",{"measure":21,"description":22,"timeFrame":23},"Prevalence of Invasive Coronary Functional Phenotypes","Proportion of participants classified as having coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal invasive coronary physiology.","At index invasive coronary procedure",{"measure":25,"description":26,"timeFrame":23},"Prevalence of Coronary Morphological Abnormalities Assessed by Optical Coherence Tomography","Proportion of participants with non-obstructive atherosclerotic plaque, plaque rupture, plaque erosion, thin-cap fibroatheroma, macrophage accumulation, positive remodeling, myocardial bridging, spontaneous coronary artery dissection, or other optical coherence tomography findings.",{"measure":28,"description":29,"timeFrame":30},"Change in Perceived Stress Assessed by the Perceived Stress Scale-4","Change in Perceived Stress Scale-4 score from baseline to 6-month and 12-month follow-up. The Perceived Stress Scale-4 is a 4-item patient-reported measure of perceived stress during the previous month. Total scores range from 0 to 16, with higher scores indicating greater perceived stress and a worse outcome.","Baseline to 6 and 12 months",{"measure":32,"description":33,"timeFrame":34},"Medication Adherence Assessed by the Modified Morisky-Green-Levine Questionnaire","Medication adherence will be assessed using the modified Morisky-Green-Levine questionnaire at 1, 6, and 12 months. The modified Morisky-Green-Levine questionnaire is a patient-reported measure of medication adherence. Scores range from 0 to 4, with higher scores indicating better medication adherence.","1, 6, and 12 months",{"measure":36,"description":37,"timeFrame":12},"Major Adverse Cardiovascular Events","Composite of death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization during follow-up.",{"measure":39,"description":40,"timeFrame":41},"Adherence to Cardiovascular Rehabilitation Assessed by Session Completion Rate","Adherence to cardiovascular rehabilitation will be assessed at 1, 6, and 12 months as the percentage of prescribed rehabilitation sessions completed. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.","During the 12-week cardiovascular rehabilitation program.",{"measure":43,"description":44,"timeFrame":34},"Adherence to Psycho-Emotional Support Assessed by Session Completion Rate","Adherence to psycho-emotional support will be assessed at 1, 6, and 12 months as the percentage of prescribed sessions completed among participants for whom this intervention is clinically indicated. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"NA","SINGLE_GROUP","All participants will undergo the same structured diagnostic and therapeutic pathway. The intervention consists of invasive coronary phenotyping followed by individualized treatment according to the functional and\u002For morphological mechanism identified. There is no randomization and no comparator arm.","TREATMENT",{"masking":52,"maskingDescription":45,"whoMasked":45},"NONE","Angina with non-obstructive coronary arteries (ANOCA) is a prevalent and frequently underdiagnosed clinical condition, particularly in women. Although obstructive epicardial coronary artery disease is absent, symptoms may be related to coronary microvascular dysfunction, epicardial or microvascular vasospasm, endothelial dysfunction, non-obstructive atherosclerotic plaque, myocardial bridging, or combined mechanisms. In routine clinical practice, many patients remain without a precise pathophysiological diagnosis after conventional angiography.\n\nThis study will evaluate a structured diagnostic and therapeutic pathway for women with ANOCA at a single academic cardiovascular center in Uruguay. Eligible participants will undergo an invasive coronary assessment performed during cardiac catheterization. The protocol will include angiographic confirmation of non-obstructive coronary arteries, invasive coronary physiology assessment, acetylcholine provocation testing for coronary vasomotor disorders, and optical coherence tomography for intracoronary morphological assessment.\n\nThe invasive findings will be integrated to classify participants according to their predominant functional and\u002For morphological phenotype. Potential phenotypes include coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, non-obstructive plaque-related abnormalities, combined mechanisms, or normal invasive coronary physiology.\n\nAfter phenotyping, participants will receive an individualized treatment plan according to the identified mechanism. This may include targeted pharmacological therapy, cardiovascular risk factor optimization, adapted cardiovascular rehabilitation, and structured psycho-emotional support when clinically indicated. The therapeutic strategy will be determined by the treating clinical team according to the study protocol and current evidence-based recommendations.\n\nParticipants will be followed for 12 months after the invasive assessment. Follow-up visits will assess angina symptoms, health-related quality of life, functional capacity, treatment adherence, adverse events, and cardiovascular outcomes. The study aims to generate local evidence on the feasibility and clinical utility of a phenotype-guided approach for women with ANOCA and to support the development of a multidisciplinary reference pathway for this condition in Uruguay.",[55],{"label":56,"type":57,"description":58,"interventionNames":59},"Phenotype-Guided Diagnostic and Therapeutic Strategy","EXPERIMENTAL","Participants will undergo a standardized invasive coronary assessment to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries. Based on the identified phenotype, participants will receive individualized treatment including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when clinically indicated.",[60,61],"Procedure: Invasive Coronary Functional and Morphological Assessment","Drug: Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":45},"PROCEDURE","Invasive Coronary Functional and Morphological Assessment","Participants will undergo invasive coronary assessment including coronary physiology measurements, acetylcholine provocation testing, and optical coherence tomography to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries.",[56],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":45},"DRUG","Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted","Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted therapy, cardiovascular risk factor optimization, or revascularization evaluation when clinically indicated.",[56],[74,80],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},"Rafael Mila, MD","CONTACT","+59824871515","9","r1000a@gmail.com",{"name":81,"role":76,"phone":82,"phoneExt":78,"email":83},"Victor Dayan, MD, PhD","+5989924871515","victordayan24@gmail.com",[85],{"facility":5,"status":45,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Montevideo","Montevideo Department","11600","Uruguay","UY",{"type":92,"coordinates":93},"Point",[94,95],-56.18816,-34.90328,{"lat":95,"lon":94},[98,101],{"name":75,"role":76,"phone":99,"phoneExt":45,"email":100},"+59824875201","cencar@hc.edu.uy",{"name":81,"role":76,"phone":99,"phoneExt":45,"email":100},{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Rafael Mila","Associate Professor of Cardiology and Head of Interventional Cardiology","100639304","invasive-evaluation-and-phenotype-guided-treatment-of-anoca-in-women-100639304",false,"NCT07593157","Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women","Invasive Functional and Morphological Coronary Assessment Followed by Phenotype-Guided Multidisciplinary Treatment in Women With Angina and Non-Obstructive Coronary Arteries: A Prospective Single-Center Interventional Study","ANOCA-UY","Inclusion Criteria:\n\n* Female participants aged 35 to 75 years.\n* Symptoms compatible with stable angina or suspected myocardial ischemia.\n* Non-obstructive coronary arteries, defined as absence of angiographic stenosis greater than or equal to 50%.\n* Ability to undergo invasive coronary assessment and clinical follow-up.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Significant structural heart disease.\n* Severe left ventricular systolic dysfunction, defined as left ventricular ejection fraction \\\u003C40%.\n* Clinically relevant contraindication to adenosine or acetylcholine, including severe asthma, untreated high-grade atrioventricular block, or known hypersensitivity.\n* Active oncological disease or life expectancy less than 12 months.\n* Inability to complete the diagnostic or therapeutic study protocol.\n* Participation in another clinical study that could interfere with the present protocol.","FEMALE","35 Years","75 Years",{"count":118,"type":119},50,"ESTIMATED","INTERVENTIONAL",[47],"This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. The diagnostic protocol will identify functional and morphological mechanisms of angina, including microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal coronary physiology.\n\nBased on the identified phenotype, participants will receive individualized multidisciplinary treatment, including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when indicated. Clinical follow-up will be performed at 1, 6, and 12 months to assess angina symptoms, quality of life, functional capacity, adherence to treatment, and cardiovascular events.",[124,125,126],"ANOCA - Angina With Non-obstructive Coronary Arteries","Coronary Microvascular Dysfunction (CMD)","Vasospastic Angina",[128,129,130,131,132],"Angina with non-obstructive coronary arteries","ANOCA","INOCA","Vasospastic angina","Coronary Microvascular Dysfunction","NOT_YET_RECRUITING","2026-05-15",{"date":136,"type":137},"2026-05-18","ACTUAL",{"date":134,"type":119},{"date":140,"type":119},"2029-04-30",{"name":5,"class":6},1]