Viewing Study NCT01398631



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Last Modification Date: 2024-10-26 @ 10:38 AM
Study NCT ID: NCT01398631
Status: COMPLETED
Last Update Posted: 2016-02-17
First Post: 2010-06-09

Brief Title: A Comparison of the TIMI GRACE and HEART Scores
Sponsor: RD Cardiologie
Organization: RD Cardiologie

Study Overview

Official Title: A Prospective Comparison of the TIMI GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HEART
Brief Summary: Various elements of patient history are checked and entered in the admission Case Recor Form CRF Three risk scores are calculated out of these elements combined with physical examination laboratory values and ECG-findings

The primary aim is to assess the positive and negative predictive values for a cardiovascular event of the three risk scores for chest pain patients

Secondary aim is to assess the sensitivity and specificity of various elements in the patient history for an acute coronary syndrome
Detailed Description: This is a prospective observational study in patients admitted to the emergency room for chest pain All patients are checked by the resident in charge immediately on admission before any lab values are known by means of an admission Case Report Form CRF consisting of classical elements of patient history risk factors medication and physical examination This CRF is filled out immediately by the resident No additional effort will be asked of the patients

Patient data during a follow up of at least 6 weeks are gathered from hospital charts

The predictive value of the three scoring systems HEART History ECG Age Risk factors Troponin TIMI Thrombolysis in Myocardial Infarction and GRACE Global Registry of Acute Coronary Events for both the discharge diagnosis and the occurrence of Major Adverse Cardiovascular Events MACE is calculated

The primary hypothesis of the study is that the HEART score is a significantly better predictor than the TIMI andor GRACE score for cardiovascular events during a six week period following admission to the emergency room

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None