Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT04017169
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2019-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
No Reflow Phenomenon Incidence and Predictors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054318', 'term': 'No-Reflow Phenomenon'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'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': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of no reflow phenomenon', 'timeFrame': '0-2 days'}], 'secondaryOutcomes': [{'measure': 'Predictors of no reflow phenomenon', 'timeFrame': '0-3 days', 'description': 'Statistical analysis of multiple variables to find independent predictors'}, {'measure': 'MACE outcomes', 'timeFrame': '30 days', 'description': '* Cardiovascular death\n* Death\n* Hearth Failure (Killip class III/IV)\n* MI\n* CVA\n* Repeat unplanned angiography\n* Repeat unplanned revascularisation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['No Reflow Phenomenon', 'STEMI']}, 'descriptionModule': {'briefSummary': 'Background No reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI). It is known to be associated with worse outcomes but predictors of no reflow are not clearly described.\n\nObjectives A single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for PPCI comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. Aiming to establish incidence for the UK population.\n\nSecondary outcomes will be to gain further insight into those presenting with STEMI for PPCI and develop a risk model to guide management and clinical outcomes of patients to 30days.\n\nMethods This study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for STEMI. Angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced TIMI flow or blush grade). Baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort is defined as all patients attending with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Cases are those subjects who suffered no reflow phenomenon, with control comparators those that had TIMI III flow and grade III myocardial blush post procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presenting with ST elevation myocardial infarction\n* Appropriate for Primary Percutaneous Coronary Intervention\n\nExclusion Criteria:\n\n* Primary Percutaneous Coronary Intervention not performed eg due to non- flow- limiting coronary artery disease\n* Unsuccessful PCI\n* Thrombolysis\n* Patients who do not survive the procedure to leave the catheterisation laboratory'}, 'identificationModule': {'nctId': 'NCT04017169', 'acronym': 'NORM-PPCI', 'briefTitle': 'No Reflow Phenomenon Incidence and Predictors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'NO Reflow Phenomenon and Comparison to the Normal Flow Population Post Primary Percutaneous Coronary Intervention for ST Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'NORM PPCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No reflow phenomenon', 'description': 'Those that during procedure experience no reflow phenomenon\n\nTo define no reflow requires:\n\n• Angiographic evidence of reopening of occluded coronary artery and successful stent placement with no evidence of flow-limiting residual stenosis (\\<50%), dissection, vessel spasm, or thrombus burden\n\nand\n\n* Angiographic documentation of a TIMI flow grade ≤II, or\n* A TIMI flow grade III with a myocardial perfusion grade 0 or I, at least 10 min after the end of PCI procedure.', 'interventionNames': ['Other: No intervention as observational study']}, {'label': 'No NRP', 'description': 'Normal angiographic coronary flow/blush post patent culprit vessel.', 'interventionNames': ['Other: No intervention as observational study']}], 'interventions': [{'name': 'No intervention as observational study', 'type': 'OTHER', 'armGroupLabels': ['No NRP', 'No reflow phenomenon']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital (Hull and east Yorkshire Hospitals NHS Trust)', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}], 'overallOfficials': [{'name': 'Jennifer A Rossington, BSc MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull University Teaching Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}