Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT06689566
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019833', 'term': 'Genistein'}], 'ancestors': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety outcome', 'timeFrame': 'At every follow-up through study completion, with an estimated average of 1 year', 'description': 'Patient reported symptoms including allergic reaction'}], 'primaryOutcomes': [{'measure': 'Change of triglyceride', 'timeFrame': 'at 3 months', 'description': 'Reduction of triglyceride level from baseline at 3 months.'}], 'secondaryOutcomes': [{'measure': 'Laboratory and functional assessment', 'timeFrame': 'at 1,3,6 months', 'description': 'Lipid profile including total cholesterol(mg/dL), LDL-C(mg/dL), HDL-C(mg/dL), triglyceride(mg/dL) and hsCRP, HOMA-IR, TNF-alpha, IL-6'}, {'measure': 'Echocardiographic assessment of ventricular function', 'timeFrame': 'at 1,3,6 months', 'description': 'echocardiographic feature of chamber function including left ventricular ejection fraction(%), left ventricular internal diameter in end diastole (cm), left atrium dimension (mm)'}, {'measure': 'Functional assessment', 'timeFrame': 'at 1,3,6 months', 'description': '6-minute walking test (m)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation'], 'conditions': ['Myocardial Infarction (MI)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if genistein works to provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis in post-myocardial infarction adults. It will also learn about the safety of genistein. The main questions it aims to answer are:\n\nDoes genistein lower triglyceride in participants? What medical problems do participants have when taking genistein? Researchers will compare the baseline, under treatment and washout period triglyceride, hsCRP to see if genistein works to decrease inflammation.\n\nParticipants will:\n\nTake genistein every day for 3 months with a fixed dose manner. Afterwards, there will be 3 months washout period.\n\nVisit the clinic once every month for checkups and tests. Keep a diary of their symptoms.', 'detailedDescription': "Background Current medical treatment for slowing the progression of atherosclerosis focus on lipid control and anti-platelet agent use. Systemic inflammation is associated with an increased risk of cardiovascular events, independent of the cholesterol level. Recent studies showed that anti-inflammatory therapy with canakinumab or colchicine led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. Genistein was reported to be associated with anti-inflammatory and lipid lowering effects in preclinical studies. Thus, we hypothesized that genistein could provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis.\n\nMethod The study is a phase 2 sing-center, dose-escalation clinical trial to evaluate the benefit of genistein compared to placebo among stable post-MI patients receiving standard of care therapy who have been selected for an elevated inflammatory burden as determined by high sensitivity C-reactive protein (hsCRP) \\> 0.1 mg/dL\n\nScreening will take place no earlier than 28 days after the index MI and on stable (at least 4 weeks) long term medication. Evaluations will include hsCRP and determination of cancer, tuberculosis status among other measurements and procedures and will be done at a cardiology clinic. For patients who underwent percutaneous coronary intervention (PCI) at different hospital admission than the qualifying MI; screening can be initiated no earlier than 28 days following this procedure.\n\nIntervention Patients will be screened for suitability of genistein treatment, and the trial would be initiated after informed consent. After initiation, the patients will receive genistein 250mg BID orally for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.\n\nFollow-up Laboratory data would be checked 0, 1, 3, 6 months as well as clinics follow-up. Echocardiography and 6-minute walking test will be checked at 0, 3 months. Major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, hospitalization for heart failure, or confirmed death from cardiovascular causes will be documented. Further follow-up would be arranged according to local guidelines until 2027/12/31 then according to patient's condition and local medical guidance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Written informed consent.\n2. Age ≥ 18 years.\n3. History of spontaneous myocardial infarction at least 28 days before recruitment.\n4. hsCRP ≥ 0.1 mg/dL\n5. BMI ≥ 27\n\nExclusion criteria\n\n1. Pregnant or nursing (lactating) women\n2. Women of child-bearing potential\n3. Planned coronary revascularization (PCI or CABG)\n4. Major non-cardiac surgical or endoscopic procedure within past 6 months\n5. Symptomatic patients with Class IV heart failure (HF) (New York Heart Association \\[NYHA\\].\n6. Uncontrolled hypertension\n7. Uncontrolled diabetes\n8. History or evidence of active tuberculosis (TB) infection\n9. Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy\n10. BMI \\> 40 kg/m2\n11. Active cancer under treatment'}, 'identificationModule': {'nctId': 'NCT06689566', 'briefTitle': 'Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients', 'orgStudyIdInfo': {'id': '202404082RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'genistein group', 'interventionNames': ['Dietary Supplement: genistein']}], 'interventions': [{'name': 'genistein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the patients will receive genistein 250mg BID orally for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.', 'armGroupLabels': ['genistein group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'CHO-KAI WU, MD, PhD', 'role': 'CONTACT', 'email': 'wuchokai@gmail.com', 'phone': '0972652310'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Cho-Kai Wu', 'role': 'CONTACT', 'email': 'wuchokai@gmail.com', 'phone': '886-972652310'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}