A Comparison of the TIMI, GRACE and HEART Scores (HEART)

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 2440

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Meander Medical Centre
  • Apeldoorn, Netherlands
    • Gelre Hospital
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Den Haag, Netherlands
    • Medical Centre Haaglanden
  • Groningen, Netherlands
    • University Medical Centre Groningen
  • Leidschendam, Netherlands
    • Medical Centrum Haaglanden
  • Nieuwegein, Netherlands
    • St Antonius hospital
  • Utrecht, Netherlands
    • University Medical Centre Utrecht
  • Utrecht, Netherlands
    • St Antonius hospital
  • Woerden, Netherlands
    • Hofpoort Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients presentating with chest pain in one of the participating hospitals.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Group; All included patients presented with chest pain at the emergency room within the inclusion period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: R&D Cardiologie
• Collaborators: Sanofi; Novartis
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: ACS; Risk scores; HEART-score
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: Z-08.27