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

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ClinicalTrials.gov Identifier: NCT01756846
Recruitment Status : Completed
First Posted : December 28, 2012
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
A.W. Hoes, UMC Utrecht

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Chest Pain
Interventions Other: usual care
Other: use of HEART risk score
Enrollment 3666
Recruitment Details Inclusion at 9 Dutch Emergency departments, recruitment period between 1-7-2013 and 31-8-2014.
Pre-assignment Details Exclusion criteria were evident ST-segment elevation myocardial infarction, language barriers, recurrent presentation, or unable or unwilling to give informed consent.
Arm/Group Title Usual Care HEART Care
Hide Arm/Group Description usual care was defined as 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).

HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.

During 14 months, patients presenting with chest pain to the emergency department (ED) of participating hospitals were included in the study. First, all hospitals applied '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 sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines.

Period Title: Overall Study
Started 1833 1833
Completed 1827 1821
Not Completed 6 12
Reason Not Completed
Lost to Follow-up             5             10
Withdrawal by Subject             1             2
Arm/Group Title Usual Care HEART Care Total
Hide Arm/Group Description standard care of the cardiologist according to current cardiological guidelines standard care of the cardiologist according to current cardiological guidelines, complemented by calculation of the HEART score and following the recommended policy Total of all reporting groups
Overall Number of Baseline Participants 1827 1821 3648
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1827 participants 1821 participants 3648 participants
62  (14) 62  (14) 62  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1827 participants 1821 participants 3648 participants
Female
822
  45.0%
846
  46.5%
1668
  45.7%
Male
1005
  55.0%
975
  53.5%
1980
  54.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Netherlands Number Analyzed 1827 participants 1821 participants 3648 participants
1827
 100.0%
1821
 100.0%
3648
 100.0%
1.Primary Outcome
Title MACE (Major Adverse Cardiac Events)
Hide Description 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
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care HEART Care
Hide Arm/Group Description:
usual care was defined as 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).
HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.
Overall Number of Participants Analyzed 1827 1821
Measure Type: Count of Participants
Unit of Measure: Participants
405
  22.2%
345
  18.9%
2.Secondary Outcome
Title Cost-effectiveness (Costs, QoL, QALYs)
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cost-effectiveness analysis was performed in 5 of 9 hospitals
Arm/Group Title Usual Care HEART Care
Hide Arm/Group Description:
usual care was defined as 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).
HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.
Overall Number of Participants Analyzed 1176 804
Mean (95% Confidence Interval)
Unit of Measure: years
0.16
(0.16 to 0.17)
0.17
(0.17 to 0.18)
3.Other Pre-specified Outcome
Title Gender-related Differences in Risk for MACE
Hide Description with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc)
Time Frame 3 months
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Pre-specified Subgroup Analyses
Hide Description

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.

Time Frame 6 weeks
Outcome Measure Data Not Reported
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care HEART Care
Hide Arm/Group Description usual care was defined as 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).

HEART care: usual care, complemented by calculation of the HEART score and following the recommended policy.

During 14 months, patients presenting with chest pain to the ED of participating hospitals were included in the study. First, all hospitals applied '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 sequentially started to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 were advised not be admitted to the hospital, and patients with a HEART score above 3 were advised to be treated according to current guidelines.

All-Cause Mortality
Usual Care HEART Care
Affected / at Risk (%) Affected / at Risk (%)
Total   9/1827 (0.49%)      5/1821 (0.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care HEART Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   405/1827 (22.17%)      345/1821 (18.95%)    
Cardiac disorders     
Cardiac ischemia   400/1827 (21.89%)  400 329/1821 (18.07%)  329
Death   9/1827 (0.49%)  9 5/1821 (0.27%)  5
Significant stenosis (PCI, CABG, conservative)   290/1827 (15.87%)  290 247/1821 (13.56%)  247
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care HEART Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1827 (0.00%)      0/1821 (0.00%)    
Hesitance to refrain from admission and testing in patients with low scores could explain the low impact on health care costs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Judith Poldervaart
Organization: University Medical Center Utrectht
Phone: 008875 55105
Other Publications:
Responsible Party: A.W. Hoes, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01756846     History of Changes
Other Study ID Numbers: 80-82310-97-12154
First Submitted: December 20, 2012
First Posted: December 28, 2012
Results First Submitted: April 26, 2017
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019