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

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Novartis
Information provided by (Responsible Party):
Barbra Backus, R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT01398631
First received: June 9, 2010
Last updated: February 16, 2016
Last verified: February 2016
  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


Enrollment: 2440
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: December 2010 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
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
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
  More Information

Responsible Party: Barbra Backus, MD, PhD, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT01398631     History of Changes
Other Study ID Numbers: Z-08.27 
Study First Received: June 9, 2010
Last Updated: February 16, 2016
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
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016