A Comparison of the TIMI, GRACE and HEART Scores

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by R&D Cardiologie.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sanofi
Novartis
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT01398631
First received: June 9, 2010
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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
Acute Coronary Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by R&D Cardiologie:

Primary Outcome Measures:
  • Occurence of MACE (Major Adverse Cardiac Events) [ Time Frame: 6 weeks after presentation ] [ Designated as safety issue: No ]
    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:
  • The number of patients undergoing Coronary ArterioGraphy (CAG) [ Time Frame: Three months after presentation ] [ Designated as safety issue: No ]
  • The number of patients suffering Acute Coronary Syndrome (ACS) [ Time Frame: 3 months after presentation ] [ Designated as safety issue: No ]
    According to adjudication committee


Estimated Enrollment: 2000
Study Start Date: June 2009
Estimated Study Completion Date: July 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
All included patients presented with chest pain at the emergency room within the inclusion period.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398631

Contacts
Contact: Barbra Backus, MD 0031647944555 barbrabackus@hotmail.com
Contact: Gijs Mast, MD 0031306099111 ext 953 e.g.mast@antoniusziekenhuis.nl

Locations
Netherlands
Meander Medical Centre Recruiting
Amersfoort, Netherlands
Contact: Arend Mosterd, MD, PhD    0031335805050    a.mosterd@meandermc.nl   
Gelre Hospital Recruiting
Apeldoorn, Netherlands
Contact: Richard Braam, MD, PhD    0031555818181    r.braam@gelre.nl   
Contact: Bjorn Groenemeijer, MD, PhD    0031555818181    b.groenemeijer@gelre.nl   
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
Contact: Stefan Monnink, MD, PhD    0031152603060    monnink@rdgg.nl   
Medical Centre Haaglanden Recruiting
Den Haag, Netherlands
Contact: Alexander Wardeh, MD    0031703302000    a.wardeh@mchaaglanden.nl   
University Medical Centre Groningen Not yet recruiting
Groningen, Netherlands
Contact: Rene Tio, MD,PhD    0031503616161    r.a.tio@thorax.umcg.nl   
Medical Centrum Haaglanden Recruiting
Leidschendam, Netherlands
Contact: Rolf Veldkamp, MD, PhD    0031703574444    velrol@mchaaglanden.nl   
Contact: Peter Tolen, MD       ph_tolen@hotmail.com   
St Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Barbra Backus, MD    0031647944555    barbrabackus@hotmail.com   
Contact: Gijs Mast, MD    00316099111 ext 953    e.g.mast@antoniusziekenhuis.nl   
St Antonius Hospital Recruiting
Utrecht, Netherlands
Contact: Niels Plantenga, MD    0031883203000    n.plantenga@antoniusziekenhuis.nl   
University Medical Centre Utrecht Recruiting
Utrecht, Netherlands
Contact: Wouter Tietge, MD       wouter@tietge.nl   
Contact: Pieter Doevendans, MD,PhD,Prof    0031887555555    p.doevendans@umcutrecht.nl   
Hofpoort Hospital Recruiting
Woerden, Netherlands
Contact: Jacob Six, MD, PhD    0031653192756    jsix@zuwe.nl   
Sponsors and Collaborators
R&D Cardiologie
Sanofi
Novartis
Investigators
Study Chair: Pieter Doevendans, MD,PhD,Prof University Medical Centre Utrecht
Principal Investigator: Barbra Backus, MD St Antionius Hospital Nieuwegein
Study Director: Jacob Six, MD, PhD Hofpoort Hospital Woerden
  More Information

No publications provided

Responsible Party: Barbra Backus, MD, St Antonius Hospital Nieuwegein
ClinicalTrials.gov Identifier: NCT01398631     History of Changes
Other Study ID Numbers: Z-08.27
Study First Received: June 9, 2010
Last Updated: July 25, 2011
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by R&D Cardiologie:
Risk scores
ACS
HEART-score

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014