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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398631
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Barbra Backus, 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.

Condition or disease
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
Actual Enrollment : 2440 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. The number of patients undergoing Coronary ArterioGraphy (CAG) [ Time Frame: Three months after presentation ]
  2. The number of patients suffering Acute Coronary Syndrome (ACS) [ Time Frame: 3 months after presentation ]
    According to adjudication committee

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients presentating with chest pain in one of the participating hospitals.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398631

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, Netherlands
Sponsors and Collaborators
R&D Cardiologie
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

Responsible Party: Barbra Backus, MD, PhD, R&D Cardiologie Identifier: NCT01398631     History of Changes
Other Study ID Numbers: Z-08.27
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Barbra Backus, R&D Cardiologie:
Risk scores

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases