A Comparison of the TIMI, GRACE and HEART Scores

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01398631
• Lead Sponsor: R&D Cardiologie

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 and/or GRACE score for cardiovascular events during a six week period following admission to the emergency room.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-06-09
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-16
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2440

Inclusion Criteria

• any patient visiting the cardiology emergency room due to chest pain

Exclusion Criteria

• chest pain clearly due to rhythm disturbances or acute heart failure
• concomitant non cardiac disease with expected fatal outcome within 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of MACE (Major Adverse Cardiac Events)	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)

Secondary Outcome Measures

Name	Time	Method
The number of patients undergoing Coronary ArterioGraphy (CAG)	Three months after presentation
The number of patients suffering Acute Coronary Syndrome (ACS)	3 months after presentation	According to adjudication committee

Trial Locations

Locations (9)

Meander Medical Centre; 🇳🇱 Amersfoort, Netherlands

Gelre Hospital; 🇳🇱 Apeldoorn, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Medical Centre Haaglanden; 🇳🇱 Den Haag, Netherlands

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands

Medical Centrum Haaglanden; 🇳🇱 Leidschendam, Netherlands

St Antonius Hospital; 🇳🇱 Utrecht, Netherlands

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

Hofpoort Hospital; 🇳🇱 Woerden, Netherlands