Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 2:31 PM
Study NCT ID:
NCT03365505
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frailty Assessment in Elderly Patients With Acute Coronary Syndrome
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-03', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale', 'timeFrame': 'Through hospitalization , an average of 1 week', 'description': 'Subjective frailty assessment made by a cardiologist during hospitalization with acute coronary syndrome- "eye ball" testing'}, {'measure': 'An objective frailty assessment using Fried score and Edmonton frailty scale will be compared to a subjective eye ball frailty assessment', 'timeFrame': 'Through hospitalization , an average of 1 week', 'description': 'An objective frailty assessment based on Fried score and Edmonton frailty scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frail Elderly Syndrome', 'Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing.\n\nin this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.', 'detailedDescription': 'elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale.\n\nThe cardiologist will not be aware of the objective frailty assessment result.\n\nThe eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'elderly patient admitted to our hospital with acute coronary syndrome: unstable angina or non ST elevation myocardial infarction who are aged 80 and above and are hemodinamically stable.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient admitted to Meir hospital with acute coronary syndrome\n* Age: 80 years old and older\n* eligible for signing an informed concent\n\nExclusion Criteria:\n\n* uncontrolled heart failure ( pulmonary edema or the use of iv diuretics)\n* cardiogenic shock\n* fever st elevation myocardial infarction'}, 'identificationModule': {'nctId': 'NCT03365505', 'briefTitle': 'Frailty Assessment in Elderly Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Frailty Assessment in Elderly Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': '00-34-17-MMC'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}