Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 7:59 PM
Study NCT ID:
NCT04378504
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Hospital Course of Acute Coronary Artery Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-05-04', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation during hospitalization', 'timeFrame': '1 day', 'description': 'all causes of death, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason'}], 'secondaryOutcomes': [{'measure': 'all-cause and cardiovascular mortality', 'timeFrame': '1 month', 'description': 'all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the two groups, calculation of the average number of serious events per patient : One month follow up (by phone or medical consultation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute coronary syndromes', 'Intensive care unit', 'Coronary angiography', 'In hospital events'], 'conditions': ['Acute Coronary Syndrome', 'Intensive Care Unit Syndrome']}, 'referencesModule': {'references': [{'pmid': '37510718', 'type': 'DERIVED', 'citation': 'Akodad M, Meunier PA, Padovani C, Cayla G, Zitouni W, Macia JC, Robert P, Steinecker M, Roubille F, Leclercq F. Identification of Low- versus High-Risk Acute Coronary Syndrome for a Selective ECG Monitoring Strategy. J Clin Med. 2023 Jul 11;12(14):4604. doi: 10.3390/jcm12144604.'}]}, 'descriptionModule': {'briefSummary': 'While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Evaluation of complications occurring in a contemporary population of ACS may help to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these data may be an opportunity for testing of strategies to refine triage to less costly hospital care units. The investigators thus want to compare, through an observational and prospective study, the event rate of two groups of patients with ACS admitted to ICU . Patients are classified as "high risk" and "low risk" according to specific medical criteria validated in the literature. The study will include all consecutive patients admitted for NSTACS and STACS admitted to the intensive care department of the Montpellier university hospital with the diagnosis of ACS confirmed by coronary angiography.\n\nOur primary goal is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, painful recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason.\n\nOur hypothesis is that low-risk patients will have very few events and no fatal events and that they could not require intensive care unit admission .', 'detailedDescription': "All patients admitted in the ICU Montpellier University center for ACS from May 2019 to May 2020 will be evaluated and classed as low risk patients (groupe LR) or not low risk patients (NLR) after coronary angiography evaluation. High risk criteria will include age \\>80 years, severe comorbidities, unstable hemodynamic or rhythmic state requiring specific therapeutic intervention, failure of reperfusion or unsatisfactory result of angioplasty, patients with residual coronary lesions requiring further revascularization, left ventricular ejection fraction \\<40%. Patients who have not received optimal antithrombotic treatment during angioplasty for any reason will also be considered at high risk, as will patients at risk of bleeding due to antecedent or associated pathology or taking a long-term anticoagulant treatment. For the specific case of SCA with ST segment elevation, they will all be included in the group, except for patients who have been successfully reperfused less than 3 hours after the onset of pain or who have an open artery during coronary angiography performed within the first 3 hours.\n\nOur primary endpoint is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, chest pain recurrence requiring new coronary angiography, any secondary transfer to intensive care for any reason. Secondary endpoints include evaluation of adverse events (all-cause and cardiovascular mortality, unplanned hospitalization for cardiac and non-cardiac causes) at 1 month follow-up in the 2 groups, length of hospitalization of the two groups, calculation of the average number of serious events per patient The low-risk group event rate is estimated at 3 percent without any fatal events. It is estimated at 15 percent in the high risk group.\n\nAssuming a frequency of the event of 3% in the low risk group and 15% in the high risk group, it is necessary to include at least 269 patients, including 196 patients in the high risk group and 73 patients in the low risk group (for a power of 90% and an alpha risk of 5%).\n\nOur hypothesis is that low-risk patients, about 1/3 of ACS admission in ICU, will have very few events and no fatal events and that they don't need intensive care admission"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* ACS with or without ST elevation during the inclusion period (May 2019 to May 2020)\n* Patients all admitted in ICU after coronary angiography and angioplasty if required\n\nExclusion criteria:\n\n* Patients not admitted in ICU\n* Patients without coronary angiography evaluation\n* lack of patient consent'}, 'identificationModule': {'nctId': 'NCT04378504', 'acronym': 'HACSA', 'briefTitle': 'In Hospital Course of Acute Coronary Artery Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area', 'orgStudyIdInfo': {'id': 'RECHMPL20_0271'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACS', 'description': 'All patients admitted in the ICU for ACS after coronary angiography evaluation between May 2019 and May 2020'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florence Leclercq, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}