A Comparison of the TIMI, GRACE and HEART Scores (HEART)
|ClinicalTrials.gov Identifier: NCT01398631|
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : February 17, 2016
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.
|Condition or disease|
|Acute Coronary Syndrome|
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 and/or GRACE score for cardiovascular events during a six week period following admission to the emergency room.
|Study Type :||Observational|
|Actual Enrollment :||2440 participants|
|Official Title:||A Prospective Comparison of the TIMI, GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room|
|Study Start Date :||June 2009|
|Primary Completion Date :||December 2010|
|Study Completion Date :||July 2011|
All included patients presented with chest pain at the emergency room within the inclusion period.
- Occurence of MACE (Major Adverse Cardiac Events) [ Time Frame: 6 weeks after presentation ]The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)
- The number of patients undergoing Coronary ArterioGraphy (CAG) [ Time Frame: Three months after presentation ]
- The number of patients suffering Acute Coronary Syndrome (ACS) [ Time Frame: 3 months after presentation ]According to adjudication committee
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398631
|Meander Medical Centre|
|Reinier de Graaf Gasthuis|
|Medical Centre Haaglanden|
|Den Haag, Netherlands|
|University Medical Centre Groningen|
|Medical Centrum Haaglanden|
|St Antonius Hospital|
|St Antonius Hospital|
|University Medical Centre Utrecht|
|Study Chair:||Pieter Doevendans, MD,PhD,Prof||UMC Utrecht|
|Principal Investigator:||Barbra Backus, MD||St Antionius Hospital Nieuwegein|
|Study Director:||Jacob Six, MD, PhD||Hofpoort Hospital Woerden|