A Comparison of the TIMI, GRACE and HEART Scores
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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 |
- 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)
- 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 |
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
Contacts and Locations| Contact: Barbra Backus, MD | 0031647944555 | barbrabackus@hotmail.com |
| Contact: Gijs Mast, MD | 0031306099111 ext 953 | e.g.mast@antoniusziekenhuis.nl |
| 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 | |
| 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 June 18, 2013