A Comparison of the TIMI, GRACE and HEART Scores

Acute Coronary Syndrome Clinical Trial

— HEART  

Official title:

A Prospective Comparison of the TIMI, GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01398631
• Other study ID #: Z-08.27
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: February 16, 2016
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2016
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2440
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Netherlands	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	Nieuwegein
Netherlands	St Antonius Hospital	Utrecht
Netherlands	University Medical Centre Utrecht	Utrecht
Netherlands	Hofpoort Hospital	Woerden

Sponsors (3)

Lead Sponsor	Collaborator
R&D Cardiologie	Novartis, Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of MACE (Major Adverse Cardiac Events)	The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)	6 weeks after presentation	No
Secondary	The number of patients undergoing Coronary ArterioGraphy (CAG)		Three months after presentation	No
Secondary	The number of patients suffering Acute Coronary Syndrome (ACS)	According to adjudication committee	3 months after presentation	No