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A Comparison of the TIMI, GRACE and HEART Scores

NCT ID: NCT01398631

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

R&D Cardiologie

OTHER

Sponsor Role lead

Responsible Party

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Barbra Backus

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pieter Doevendans, MD,PhD,Prof

Role: STUDY_CHAIR

UMC Utrecht

Barbra Backus, MD

Role: PRINCIPAL_INVESTIGATOR

St Antionius Hospital Nieuwegein

Jacob Six, MD, PhD

Role: STUDY_DIRECTOR

Hofpoort Hospital Woerden

Locations

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Meander Medical Centre

Amersfoort, , Netherlands

Site Status

Gelre Hospital

Apeldoorn, , Netherlands

Site Status

Reinier de Graaf Gasthuis

Delft, , Netherlands

Site Status

University Medical Centre Groningen

Groningen, , Netherlands

Site Status

Medical Centrum Haaglanden

Leidschendam, , Netherlands

Site Status

St Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Medical Centre Haaglanden

The Hague, , Netherlands

Site Status

St Antonius Hospital

Utrecht, , Netherlands

Site Status

University Medical Centre Utrecht

Utrecht, , Netherlands

Site Status

Hofpoort Hospital

Woerden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Z-08.27

Identifier Type: -

Identifier Source: org_study_id

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