Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-14 @ 2:45 AM
Study NCT ID:
NCT01473433
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2011-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T).', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Regenerative medicine', 'Myocardial infarction'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '21576133', 'type': 'BACKGROUND', 'citation': 'Galvez-Monton C, Prat-Vidal C, Roura S, Farre J, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Aris A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67. doi: 10.1093/cvr/cvr136. Epub 2011 May 16.'}, {'pmid': '22137092', 'type': 'BACKGROUND', 'citation': 'Galvez-Monton C, Prat-Vidal C, Roura S, Soler-Botija C, Llucia-Valldeperas A, Diaz-Guemes I, Sanchez-Margallo FM, Bayes-Genis A. Post-infarction scar coverage using a pericardial-derived vascular adipose flap. Pre-clinical results. Int J Cardiol. 2013 Jun 20;166(2):469-74. doi: 10.1016/j.ijcard.2011.11.019. Epub 2011 Dec 2.'}, {'pmid': '27322478', 'type': 'DERIVED', 'citation': 'Bayes-Genis A, Gastelurrutia P, Camara ML, Teis A, Lupon J, Llibre C, Zamora E, Alomar X, Ruyra X, Roura S, Revilla A, San Roman JA, Galvez-Monton C. First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar. EBioMedicine. 2016 May;7:248-54. doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.', 'detailedDescription': 'This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myocardium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established transmural myocardial infarction non candidate to revascularization (\\>3 months-old)\n* Candidate to coronary by-pass for other territories different from the previous transmural infarct.\n* \\> 18 years of age, male or female, capable of giving an informed consent.\n\nExclusion Criteria:\n\n* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.\n* Severe valvular disease candidate for surgical restoration.\n* Candidate to ventricular remodeling.\n* Contraindication for NMR (creatinin clearance \\<30 ml/min/1.73m2, metallic implants, claustrophobia).\n* Severe renal or hepatic failure.\n* Abnormal laboratory tests (no explanation at the time of inclusion).\n* Previous cardiac intervention.\n* High surgical risk (Euroscore 2).\n* Pregnant or breast feeding women.'}, 'identificationModule': {'nctId': 'NCT01473433', 'acronym': 'adiFLAP', 'briefTitle': 'Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Randomized Trial to Evaluate the Safety and Efficacy of a New Surgical Approach to Cardiac Regeneration: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)', 'orgStudyIdInfo': {'id': 'ICREC-2011-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'adiFLAP', 'description': 'Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.', 'interventionNames': ['Procedure: Pericardial adipose pedicle (adiFLAP) transposition.']}], 'interventions': [{'name': 'Pericardial adipose pedicle (adiFLAP) transposition.', 'type': 'PROCEDURE', 'description': 'Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. A non-revascularizable area will be considered whenever a transmural necrosis is detected by means of gadolinium contrast using MRI.', 'armGroupLabels': ['adiFLAP']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Germans Trias Research Institute; Germans Trias University Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Cardiology Service', 'investigatorFullName': 'Antoni Bayés Genís', 'investigatorAffiliation': 'Germans Trias i Pujol Hospital'}}}}