Clinical trial NCT01398631: A Comparison of the TIMI, GRACE and HEART Scores
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Risk scores
ACS
HEART-score
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Novartis
First posted: 2011-07-20
Enrollment: 2440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presentating with chest pain in one of the participating hospitals.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of MACE (Major Adverse Cardiac Events)
timeFrame: 6 weeks after presentation
Secondary outcomes:
measure: The number of patients undergoing Coronary ArterioGraphy (CAG)
timeFrame: Three months after presentation
measure: The number of patients suffering Acute Coronary Syndrome (ACS)
timeFrame: 3 months after presentation
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Centre
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Haag
country: Netherlands
facility: Medical Centre Haaglanden
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Leidschendam
country: Netherlands
facility: Medical Centrum Haaglanden
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Utrecht
country: Netherlands
facility: St Antonius Hospital
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
city: Woerden
country: Netherlands
facility: Hofpoort Hospital
Study officials:
affiliation: UMC Utrecht
name: Pieter Doevendans, MD,PhD,Prof
role: STUDY_CHAIR
affiliation: St Antionius Hospital Nieuwegein
name: Barbra Backus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hofpoort Hospital Woerden
name: Jacob Six, MD, PhD
role: STUDY_DIRECTOR
References: