Chest PainHEART-ImpactNCT01756846
Impact on Management of the HEART Risk Score in Chest Pain Patients
A study testing use of HEART risk score in people with Chest Pain, run by UMC Utrecht at 9 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain
- What is being tested?
- use of HEART risk score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,666 participants
- Where
- 9 sitesNetherlands
- Study dates
- Jul 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Amstelland Hospital
Amstelveen
VU Medical Center
Amsterdam
Gelderse Vallei
Ede
Catharina Hospital
Eindhoven
Atrium Medical Center
Heerlen
St. Antonius Hospital
Nieuwegein
Diakonessenhuis
Utrecht
University Medical Center
Utrecht
Zuwe Hofpoort
Woerden
About this study
Official title: 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.
Read the 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.
- Conditions
- Chest Pain
- Being tested
- usual care, use of HEART risk score
- Keywords
- HEART score, risk score, impact, chest pain
- Medical subject headings
- Chest Pain, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual careOther
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 scoreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| usual care | Other | 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). Receives: Other: usual care |
| use of HEART risk score | Other | see intervention Receives: Other: use of HEART risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Adverse Cardiac Events)
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
Measured: 6 weeks
Secondary outcomes (1)
Cost-effectiveness (Costs, QoL, QALYs)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- this is a stepped wedge cluster randomized trial, meaning it is both parallel and cross-over. 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, A.W. Hoes, UMC Utrecht
- Investigators
- Arno W Hoes, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756846
- Sponsor's protocol ID
- 80-82310-97-12154
- Acronym
- HEART-Impact
- Status last verified
- Aug 2018
- First submitted
- 20 Dec 2012
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No plans, always interested in collaboration
Publications
Backus BE, Six AJ, Kelder JH, Gibler WB, Moll FL, Doevendans PA. Risk scores for patients with chest pain: evaluation in the emergency department. Curr Cardiol Rev. 2011 Feb;7(1):2-8. doi: 10.2174/157340311795677662.
PubMed 22294968Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.
PubMed 20802272Six AJ, Backus BE, Doevendans PA. Rapid diagnostic protocol for patients with chest pain. Lancet. 2011 Jul 30;378(9789):398; author reply 398-9. doi: 10.1016/S0140-6736(11)61204-X. No abstract available.
PubMed 21803199Six AJ, Backus BE, Kingma A, Kaandorp SI. Consumption of diagnostic procedures and other cardiology care in chest pain patients after presentation at the emergency department. Neth Heart J. 2012 Dec;20(12):499-504. doi: 10.1007/s12471-012-0322-6.
PubMed 23090421Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6. doi: 10.1007/BF03086144.
PubMed 18665203Nieuwets A, Poldervaart JM, Reitsma JB, Buitendijk S, Six AJ, Backus BE, Hoes AW, Doevendans PA. Medical consumption compared for TIMI and HEART score in chest pain patients at the emergency department: a retrospective cost analysis. BMJ Open. 2016 Jun 16;6(6):e010694. doi: 10.1136/bmjopen-2015-010694.
PubMed 27311905Poldervaart JM, Reitsma JB, Koffijberg H, Backus BE, Six AJ, Doevendans PA, Hoes AW. The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial. BMC Cardiovasc Disord. 2013 Sep 26;13:77. doi: 10.1186/1471-2261-13-77.
PubMed 24070098Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.
PubMed 23465250Poldervaart JM, Reitsma JB, Backus BE, Koffijberg H, Veldkamp RF, Ten Haaf ME, Appelman Y, Mannaerts HFJ, van Dantzig JM, van den Heuvel M, El Farissi M, Rensing BJWM, Ernst NMSKJ, Dekker IMC, den Hartog FR, Oosterhof T, Lagerweij GR, Buijs EM, van Hessen MWJ, Landman MAJ, van Kimmenade RRJ, Cozijnsen L, Bucx JJJ, van Ofwegen-Hanekamp CEE, Cramer MJ, Six AJ, Doevendans PA, Hoes AW. Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial. Ann Intern Med. 2017 May 16;166(10):689-697. doi: 10.7326/M16-1600. Epub 2017 Apr 25.
PubMed 28437795Poldervaart JM, Langedijk M, Backus BE, Dekker IMC, Six AJ, Doevendans PA, Hoes AW, Reitsma JB. Comparison of the GRACE, HEART and TIMI score to predict major adverse cardiac events in chest pain patients at the emergency department. Int J Cardiol. 2017 Jan 15;227:656-661. doi: 10.1016/j.ijcard.2016.10.080. Epub 2016 Oct 30.
PubMed 27810290
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Study of the HEART Score in the Management of Patients With Chest Pain Presenting in the Emergency Room
- ClinicalTrials.gov ID
- NCT01756846
- Acronym / sponsor ID
- HEART-Impact / 80-82310-97-12154
- Conditions
- Chest Pain
- Keywords
- HEART score, risk score, impact, chest pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,666 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- this is a stepped wedge cluster randomized trial, meaning it is both parallel and cross-over. 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).
| Arm | Type | Receives |
|---|---|---|
| usual care | Other | Other: usual careDaily 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). |
| use of HEART risk score | Other | Other: use of HEART risk scoresee intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual careDuring 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 | usual care |
| use of HEART risk scoreDuring 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 |
Primary outcome
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
1 secondary outcome
Cost-effectiveness (Costs, QoL, QALYs)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22294968Backus BE, Six AJ, Kelder JH, Gibler WB, Moll FL, Doevendans PA. Risk scores for patients with chest pain: evaluation in the emergency department. Curr Cardiol Rev. 2011 Feb;7(1):2-8. doi: 10.2174/157340311795677662.
- Background: PubMed 20802272Backus BE, Six AJ, Kelder JC, Mast TP, van den Akker F, Mast EG, Monnink SH, van Tooren RM, Doevendans PA. Chest pain in the emergency room: a multicenter validation of the HEART Score. Crit Pathw Cardiol. 2010 Sep;9(3):164-9. doi: 10.1097/HPC.0b013e3181ec36d8.
- Background: PubMed 21803199Six AJ, Backus BE, Doevendans PA. Rapid diagnostic protocol for patients with chest pain. Lancet. 2011 Jul 30;378(9789):398; author reply 398-9. doi: 10.1016/S0140-6736(11)61204-X. No abstract available.
- Background: PubMed 23090421Six AJ, Backus BE, Kingma A, Kaandorp SI. Consumption of diagnostic procedures and other cardiology care in chest pain patients after presentation at the emergency department. Neth Heart J. 2012 Dec;20(12):499-504. doi: 10.1007/s12471-012-0322-6.
- Background: PubMed 18665203Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6. doi: 10.1007/BF03086144.
- Background: PubMed 27311905Nieuwets A, Poldervaart JM, Reitsma JB, Buitendijk S, Six AJ, Backus BE, Hoes AW, Doevendans PA. Medical consumption compared for TIMI and HEART score in chest pain patients at the emergency department: a retrospective cost analysis. BMJ Open. 2016 Jun 16;6(6):e010694. doi: 10.1136/bmjopen-2015-010694.
- Background: PubMed 24070098Poldervaart JM, Reitsma JB, Koffijberg H, Backus BE, Six AJ, Doevendans PA, Hoes AW. The impact of the HEART risk score in the early assessment of patients with acute chest pain: design of a stepped wedge, cluster randomised trial. BMC Cardiovasc Disord. 2013 Sep 26;13:77. doi: 10.1186/1471-2261-13-77.
- Background: PubMed 23465250Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.
- Results publication: PubMed 28437795Poldervaart JM, Reitsma JB, Backus BE, Koffijberg H, Veldkamp RF, Ten Haaf ME, Appelman Y, Mannaerts HFJ, van Dantzig JM, van den Heuvel M, El Farissi M, Rensing BJWM, Ernst NMSKJ, Dekker IMC, den Hartog FR, Oosterhof T, Lagerweij GR, Buijs EM, van Hessen MWJ, Landman MAJ, van Kimmenade RRJ, Cozijnsen L, Bucx JJJ, van Ofwegen-Hanekamp CEE, Cramer MJ, Six AJ, Doevendans PA, Hoes AW. Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial. Ann Intern Med. 2017 May 16;166(10):689-697. doi: 10.7326/M16-1600. Epub 2017 Apr 25.
- Results publication: PubMed 27810290Poldervaart JM, Langedijk M, Backus BE, Dekker IMC, Six AJ, Doevendans PA, Hoes AW, Reitsma JB. Comparison of the GRACE, HEART and TIMI score to predict major adverse cardiac events in chest pain patients at the emergency department. Int J Cardiol. 2017 Jan 15;227:656-661. doi: 10.1016/j.ijcard.2016.10.080. Epub 2016 Oct 30.
- official website of the HEART risk scoreLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. No plans, always interested in collaboration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arno W Hoes, MD, PhD principal investigator
UMC Utrecht
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of HEART risk score in people with Chest Pain, run by UMC Utrecht at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (Major Adverse Cardiac Events) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756846, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.