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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756846
First Posted: December 28, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
A.W. Hoes, UMC Utrecht
December 20, 2012
December 28, 2012
October 12, 2017
July 2013
October 2014   (Final data collection date for primary outcome measure)
MACE [ Time Frame: 6 weeks ]
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
Same as current
Complete list of historical versions of study NCT01756846 on ClinicalTrials.gov Archive Site
  • cost-effectiveness [ Time Frame: 3 months ]
    quality of life, costs and cost-effectiveness of the intervention compared with usual care.
  • MACE [ Time Frame: 3 months ]
    incidence of MACE and missed events
Same as current
  • Gender-related differences in risk for MACE [ Time Frame: 3 months ]
    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 ]

    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
Gender-related differences in risk for MACE [ Time Frame: 3 months ]
with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, PCOS, etc)
 
Impact on Management of the HEART Risk Score in Chest Pain Patients
Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Chest Pain
  • 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.
  • 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.
  • 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).
    Intervention: Other: usual care
  • use of HEART risk score
    see intervention
    Intervention: Other: use of HEART risk score

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3666
March 2015
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01756846
80-82310-97-12154
Yes
Not Provided
Not Provided
A.W. Hoes, UMC Utrecht
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Arno W Hoes, MD, PhD UMC Utrecht
UMC Utrecht
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP