Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT02463604
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in serum creatinin level (≥25% or 0,5mg/dL)', 'timeFrame': '48h after coronary angiography', 'description': 'Serum creatinin level is measured 48h after coronary angiography to assess contrast medium-induced nephropathy'}], 'secondaryOutcomes': [{'measure': 'Serum creatinin level is measured 12 months after coronary angiography and major adverse events are collected to assess long-term effects of remote ischemic preconditioning on renal function', 'timeFrame': '12 months after coronary angiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency', 'Contrast Medium-induced Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.', 'detailedDescription': 'Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.\n\nRemote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.\n\nWe will evaluate the effect of remote preconditioning on renal protection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient headed to coronary angiography\n2. Glomerular filtration rate :\n\n * ≤ 40ml/min/1,73m² (MDRD equation)\n * or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age \\> 75 years, NYHA ≥ III/IV, diabetes mellitus\n3. Signed informed consent\n\nExclusion Criteria:\n\n1. Preoperative assessment / dilated cardiomyopathy assessment\n2. Acute ST-segment elevation myocardial infarction\n3. Cardiogenic shock requiring pressor amine or systolic blood pressure \\<80mmHg\n4. Resuscitation after cardiac arrest\n5. Intra-aortic balloon pump\n6. Contraindication for the repeted use of an upper-arm pressure cuff\n7. Extra-renal epuration\n8. No health insurance coverage\n9. Legal incapacity (patients under tutorship, curatorship or judicial protection)\n10. Patient enrolled in another interventional trial or being in a washout period\n11. Incapacity/impossibility to undergo 12-month follow-up\n12. Patient refusal'}, 'identificationModule': {'nctId': 'NCT02463604', 'acronym': 'PREPARE', 'briefTitle': 'Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography', 'orgStudyIdInfo': {'id': '2014-A01281-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Ischemic Preconditioning', 'description': 'A blood pressure cuff is placed on upper arm and inflated to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.\n\nThe procedure has to be completed between 5 and 60 minutes prior coronary angiography.', 'interventionNames': ['Procedure: Coronary Angiography']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'A blood pressure cuff is placed on upper arm and inflated to 10 mmHg for 5 minutes and then deflated for 5 minutes. This cycle is repeated 3 times in total.\n\nThe procedure has to be completed between 5 and 60 minutes prior coronary angiography.', 'interventionNames': ['Procedure: Coronary Angiography']}], 'interventions': [{'name': 'Coronary Angiography', 'type': 'PROCEDURE', 'description': 'Coronary angiography is performed following usual site standards', 'armGroupLabels': ['Control', 'Remote Ischemic Preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'UH Angers - Cardiology ward', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Fabrice Prunier, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Angers, Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}