Impact on Management of the HEART Risk Score in Chest Pain Patients (HEART-Impact)

This study has been completed.
Sponsor:
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: May 27, 2015
Last verified: May 2015
  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, Poly Cystic Ovarial Syndrome (PCOS), etc)

  • pre-specified subgroup analyses [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]

    To assess whether the effectiveness and/or safety of using the HEART score is different between specific patient populations, the following pre-specified subgroup analyses will be performed:

    • Age: below and above 62 years of age (median)
    • Gender: Men vs Women
    • Diabetics vs non-diabetics
    • Ethnicity: Caucasian vs. other ethnicities


Enrollment: 3666
Study Start Date: July 2013
Study Completion Date: March 2015
Primary Completion Date: October 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 14 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 14 month period, each 1,5 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 14 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 14 month period, each 1,5 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 14 months, patients presenting with chest pain to the Emergency Department (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 14 month period, each 1,5 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
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: NCT01756846

Locations
Netherlands
Amstelland Hospital
Amstelveen, Netherlands
VU Medical Center
Amsterdam, Netherlands
Gelderse Vallei
Ede, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Atrium Medical Center
Heerlen, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Diakonessenhuis
Utrecht, Netherlands
University Medical Center
Utrecht, Netherlands
Zuwe Hofpoort
Woerden, Netherlands
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: May 27, 2015
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 August 02, 2015