Impact on Management of the HEART Risk Score in Chest Pain Patients (HEART-Impact)
This study is not yet open for participant recruitment.
Verified December 2012 by UMC Utrecht
Sponsor:
UMC Utrecht
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
A.W. Hoes, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01756846
First received: December 20, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
Aim of this study is to quantify the impact of the use of the HEART risk score on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to not using the score.
| Condition | Intervention |
|---|---|
|
Chest Pain |
Other: usual care Other: use of HEART risk score |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room |
Resource links provided by NLM:
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- MACE [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]occurrence of MACE (i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation
Secondary Outcome Measures:
- cost-effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]quality of life, costs and cost-effectiveness of the intervention compared with usual care.
- MACE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]incidence of MACE and missed events
Other Outcome Measures:
- Gender-related differences in risk for MACE [ Time Frame: 3 months ] [ Designated as safety issue: No ]with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, PCOS, etc)
| Estimated Enrollment: | 6600 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
usual care
Daily practice of the cardiologist or attending emergency doctor, in order to diagnose a patient with chest pain. In this period attending doctors assess the risk of a patient with chest pain, based on his/hers experience and various criteria (for example described in European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation, without a formal risk score).
|
Other: usual care
During 11 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 10 month period, each month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.
|
|
use of HEART risk score
see intervention
|
Other: use of HEART risk score
During 11 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 10 month period, each month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.
|
Detailed Description:
During 11 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 10 month period, each month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital (in accordance with the results of our validation studies), and patients with a HEART score above 3 will be treated according to current guidelines.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.
Exclusion Criteria:
- Children (age <18 years) are excluded from study participation. Subjects who are (for whatever reason) not able to fill in questionnaires are excluded from study participation. Legal incapacity of every patient will be assessed by the attending doctor, according to the guidelines of legal incapacity. In case of doubt, consultation of the cardiologist (primary local investigator) will be possible.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756846
Contacts
| Contact: Judith M Poldervaart, MD | 0031610167456 | j.poldervaart@umcutrecht.nl |
| Contact: Johannes B Reitsma, MD, PhD | +31 887559399 | j.b.reitsma-2@umcutrecht.nl |
Locations
| Netherlands | |
| Amstelland Hospital | Not yet recruiting |
| Amstelveen, Netherlands | |
| Principal Investigator: Herman Mannaerts | |
| VU Medical Center | Not yet recruiting |
| Amsterdam, Netherlands | |
| Principal Investigator: Yolande Appelman | |
| Rijnstate Hospital | Not yet recruiting |
| Arnhem, Netherlands | |
| Principal Investigator: Frank Willems | |
| Gelderse Vallei | Not yet recruiting |
| Ede, Netherlands | |
| Principal Investigator: Frank den Hartog | |
| Catharina Hospital | Not yet recruiting |
| Eindhoven, Netherlands | |
| Principal Investigator: Jan-melle van Dantzig | |
| Atrium Medical Center | Not yet recruiting |
| Heerlen, Netherlands | |
| Principal Investigator: Nicolette Ernst | |
| St. Antonius Hospital | Not yet recruiting |
| Nieuwegein, Netherlands | |
| Principal Investigator: Benno Rensing | |
| Diakonessenhuis | Not yet recruiting |
| Utrecht, Netherlands | |
| Principal Investigator: Jeroen Bucx | |
| University Medical Center | Not yet recruiting |
| Utrecht, Netherlands | |
| Principal Investigator: Pieter Doevendans | |
| Zuwe Hofpoort | Not yet recruiting |
| Woerden, Netherlands | |
| Principal Investigator: Jacob Six | |
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Arno W Hoes, MD, PhD | UMC Utrecht |
More Information
Additional Information:
Publications:
| Responsible Party: | A.W. Hoes, Professor of Clinical Epidemiology & General Practice and Chair, Julius Center for Health Sciences and Primary Care, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01756846 History of Changes |
| Other Study ID Numbers: | 80-82310-97-12154 |
| Study First Received: | December 20, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by UMC Utrecht:
|
HEART score risk score impact chest pain |
Additional relevant MeSH terms:
|
Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013