Acute Coronary SyndromeHEARTNCT01398631
A Comparison of the TIMI, GRACE and HEART Scores
An observational study of Acute Coronary Syndrome, run by R&D Cardiologie at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 2,440 participants
- Where
- 10 sitesNetherlands
- Study dates
- Jun 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presentating with chest pain in one of the participating hospitals.
Who may be able to join
- any patient visiting the cardiology emergency room due to chest pain
Who cannot join
- chest pain clearly due to rhythm disturbances or acute heart failure
- concomitant non cardiac disease with expected fatal outcome within 1 year
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Meander Medical Centre
Amersfoort
Gelre Hospital
Apeldoorn
Reinier de Graaf Gasthuis
Delft
University Medical Centre Groningen
Groningen
Medical Centrum Haaglanden
Leidschendam
St Antonius Hospital
Nieuwegein
Medical Centre Haaglanden
The Hague
St Antonius Hospital
Utrecht
University Medical Centre Utrecht
Utrecht
Hofpoort Hospital
Woerden
About this study
Official title: A Prospective Comparison of the TIMI, GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Risk scores, ACS, HEART-score
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | All included patients presented with chest pain at the emergency room within the inclusion period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of MACE (Major Adverse Cardiac Events)
The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)
Measured: 6 weeks after presentation
Secondary outcomes (2)
The number of patients undergoing Coronary ArterioGraphy (CAG)
Measured: Three months after presentation
The number of patients suffering Acute Coronary Syndrome (ACS)
According to adjudication committee
Measured: 3 months after presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Novartis
- Responsible party
- Principal investigator, Barbra Backus, R&D Cardiologie
- Investigators
- Pieter Doevendans, MD,PhD,Prof, Study chair, UMC UtrechtBarbra Backus, MD, Principal investigator, St Antionius Hospital NieuwegeinJacob Six, MD, PhD, Study director, Hofpoort Hospital Woerden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398631
- Sponsor's protocol ID
- Z-08.27
- Acronym
- HEART
- Status last verified
- Feb 2016
- First submitted
- 9 Jun 2010
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of the TIMI, GRACE and HEART Scores for Predicting Cardiovascular Events in Chest Pain Patients in the Emergency Room
- ClinicalTrials.gov ID
- NCT01398631
- Acronym / sponsor ID
- HEART / Z-08.27
- Conditions
- Acute Coronary Syndrome
- Keywords
- Risk scores, ACS, HEART-score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,440 participants (actual)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Collaborators
- Sanofi, Novartis
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –All included patients presented with chest pain at the emergency room within the inclusion period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presentating with chest pain in one of the participating hospitals.
Key inclusion criteria (1 listed)
- any patient visiting the cardiology emergency room due to chest pain
Key exclusion criteria (2 listed)
- chest pain clearly due to rhythm disturbances or acute heart failure
- concomitant non cardiac disease with expected fatal outcome within 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence of MACE (Major Adverse Cardiac Events)
Time frame: 6 weeks after presentation
The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)
2 secondary outcomes
The number of patients undergoing Coronary ArterioGraphy (CAG)
Time frame: Three months after presentation
The number of patients suffering Acute Coronary Syndrome (ACS)
Time frame: 3 months after presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Doevendans, MD,PhD,Prof study chair
UMC Utrecht
Barbra Backus, MD principal investigator
St Antionius Hospital Nieuwegein
Jacob Six, MD, PhD study director
Hofpoort Hospital Woerden
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by R&D Cardiologie at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of MACE (Major Adverse Cardiac Events) (time frame: 6 weeks after presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.