Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 4:46 PM
Study NCT ID:
NCT04737408
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label design'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients are randomized 1:1 to two different lipid lowering medical treatment strategies'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reproducibility assessment', 'timeFrame': '9-months', 'description': 'There will be performed 2 CTA investigations at the 9 month follow-up. Reproducibility assessment of CT derived FFR, plaque markers, FAI and V/M ratio will be performed by calculation of standard error of measurement and within-subject coefficient of variation.'}], 'primaryOutcomes': [{'measure': '18-month change in coronary flow', 'timeFrame': '18 months', 'description': 'Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)'}], 'secondaryOutcomes': [{'measure': '18-month change high risk coronary plaque volumes', 'timeFrame': '18 months', 'description': 'Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months)'}, {'measure': '18-month change in high risk coronary plaque features', 'timeFrame': '18-months', 'description': 'Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).'}, {'measure': '18-month change in coronary vessel volumes', 'timeFrame': '18-months', 'description': 'Will be assessed by calculating the vessel volume relative to myocardial mass (V/M) ratio determined from repetitive CT angiograms (0,9, and 18 months).'}, {'measure': '18-month change in indices of coronary inflammation', 'timeFrame': '18-months', 'description': 'Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease, fractional flow reserve'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).', 'detailedDescription': 'Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies ("usual" vs "intensive" care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptoms suggestive of stable coronary artery disease (CAD)\n2. No known CAD\n3. At least one coronary stenosis with \\>49% lumen reduction determined by CT angiography\n4. Sinus rhythm\n5. At least one lesion with FFRCT \\<0.81 (see below)\n6. Life expectancy \\>3 years\n7. Fertile women must use safe contraception throughout the study period\n8. Signed informed consent\n\n5\\. LDL cholesterol \\>2.0 mM (patients already on lipid lowering medical therapy \\< 3 months can be included if meeting all of the above mentioned criteria)\n\nExclusion Criteria:\n\n1. Unstable angina\n2. Known CAD\n3. Body mass index \\>40\n4. Allergy to iodinated contrast media\n5. Known statin intolerance\n6. Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)\n7. Significant left main coronary artery (stenosis \\>49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA\n8. FFRCT \\<0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or \\<0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments\n9. Pregnancy (women with age \\>45 will be screened for pregnancy)\n10. Moderate to severe liver failure\n11. Estimated glomerular filtration rate (eGFR) \\< 60 ml/min\n12. Participation in another trial\n13. Does noes not wish to participate'}, 'identificationModule': {'nctId': 'NCT04737408', 'acronym': 'FlowPromote', 'briefTitle': 'Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Influence of Intensive Lipid-lowering With Statin and Ezetimib Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain (The FLOW-PROMOTE Study)', 'orgStudyIdInfo': {'id': 'Aarhus University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '"Usual care"', 'description': '"Usual care" prevention: atorvastatin 40 mg per day for 18 months', 'interventionNames': ['Drug: Rosuvastatin 40mg']}, {'type': 'EXPERIMENTAL', 'label': '"Intensive care"', 'description': '"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months', 'interventionNames': ['Drug: Rosuvastatin 40mg']}], 'interventions': [{'name': 'Rosuvastatin 40mg', 'type': 'DRUG', 'otherNames': ['Ezetimib 10mg'], 'description': 'Rosuvastatin 40 mg', 'armGroupLabels': ['"Intensive care"', '"Usual care"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200 N', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Bjarne L Noergaard, MD, PhD', 'role': 'CONTACT', 'email': 'bnorgaard@dadlnet.dk', 'phone': '+4540136570'}, {'name': 'Martin B Mortensen, MD, PhD', 'role': 'CONTACT', 'email': 'martin.bodtker.mortensen@clin.au.dk', 'phone': '+4523882155'}, {'name': 'Jesper M Jensen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '6700', 'city': 'Esbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Niels-Peter R Sand, MD, PhD', 'role': 'CONTACT', 'email': 'npsand@webspeed.dk', 'phone': '+4528409148'}, {'name': 'Lone D Kristensen, MD', 'role': 'CONTACT', 'email': 'lone.dejbjerg@dadlnet.dk', 'phone': '+4521422813'}], 'facility': 'Southwestern Hospital Esbjerg', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '7100', 'city': 'Vejle', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Martin Busk, MD, PhD', 'role': 'CONTACT', 'email': 'martin.busk@rsyd.dk', 'phone': '+4522473224'}, {'name': 'Flemming H Steffensen, MD, PhD', 'role': 'CONTACT', 'email': 'flemming.hald@rsyd.dk', 'phone': '+4551503862'}], 'facility': 'Lillebaelt Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Bjarne L Noergaard, MD, PhD', 'role': 'CONTACT', 'email': 'bnorgaard@dadlnet.dk', 'phone': '+4540136570'}, {'name': 'Martin B Mortensen, MD, PhD', 'role': 'CONTACT', 'email': 'martin.bodtker.mortensen@clin.au.dk', 'phone': '+4523882155'}], 'overallOfficials': [{'name': 'Bjarne L Noergaard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bjarne Linde Noergaard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, PhD, FESC', 'investigatorFullName': 'Bjarne Linde Noergaard', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}