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Completed

NCT Number: NCT01756846

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

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.

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Key information

Conditions

Chest Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amstelland Hospital, Amstelveen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Other

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

Other

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.

Primary outcomes

  1. MACE (Major Adverse Cardiac Events)

    Time frame: 6 weeks

    occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation

Secondary outcomes

  1. Cost-effectiveness (Costs, QoL, QALYs)

    Time frame: 3 months

    Information on quality of life (QoL) and costs was collected in 5 of the 9 hospitals. Costs for health care resource use were calculated based on Dutch guidelines and cost tables for hospitals. Different costs were used for academic and general hospitals, and costs were adjusted for inflation by using the consumer price indices provided by Statistics Netherlands. For each patient the costs were calculated based on the observed number and type of health care resources used and the type of hospital (academic/general). Data on resource use were collected for each patient in the 5 hospitals; no data were missing. QoL was derived from the EQ-5D-3L questionnaire, consisting of 5 questions (dimensions) with 3 answers each, from which QoL scores (utility values, 0-1, the higher the better) can be directly derived. Quality-adjusted life-years (scale 0-100, higher the better) were calculated over a period of 3 months, based on the estimated QoL values at 0 weeks, 2 weeks, and 3 months.

Other outcomes

  1. 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)

  2. Pre-specified Subgroup Analyses

    Time frame: 6 weeks

    To assess whether the effectiveness and/or safety of using the HEART (history, ecg, age, risk factors, troponin) score (scale 0-10, with higher scores meaning a higher risk on MACEs) 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 ethnicity.

    RESULTS: None of the pre-specified subgroup analyses of women, elderly patients, and diabetic patients showed a statistically significantly different effect of HEART care with respect to incidence of MACEs. Ethnicity was unfortunately not possible to analyse due to too much missing data.

    NB. I am currently not working in the organisation which has the data, and this will not be possible the coming period. Therefore, I cannot provide correct numbers currently on these subgroup analyses, only conclusions. I am sorry for this inconvenience.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room

Acronym: HEART-Impact

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 28, 2012
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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