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

NCT01756846 | Completed Results DMC

• 1 other identifier: 80-82310-97-12154
• Study Type: interventional
• Target: 3,666
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chest Pain

Keywords

HEART score; risk score; impact; chest pain

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (1)

• Cost-effectiveness (Costs, QoL, QALYs)

  3 months

Other Outcomes (2)

• Gender-related Differences in Risk for MACE

  3 months

• Pre-specified Subgroup Analyses

  6 weeks

Study Arms (2)

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).

Other: usual care

use of HEART risk score

OTHER

see intervention

Other: use of HEART risk score

Interventions

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.

usual care

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.

use of HEART risk score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (9)

Amstelland Hospital

Amstelveen, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Gelderse Vallei

Ede, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Atrium Medical Center

Heerlen, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

University Medical Center

Utrecht, Netherlands

Location

Zuwe Hofpoort

Woerden, Netherlands

Location

Related Publications (10)

• 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.

  PMID: 22294968 BACKGROUND

• Backus 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.

  PMID: 20802272 BACKGROUND

• Six 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.

  PMID: 21803199 BACKGROUND

• Six 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.

  PMID: 23090421 BACKGROUND

• Six 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.

  PMID: 18665203 BACKGROUND

• Nieuwets 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.

  PMID: 27311905 BACKGROUND

• Poldervaart 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.

  PMID: 24070098 BACKGROUND

• Backus 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.

  PMID: 23465250 BACKGROUND

• Poldervaart 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.

  PMID: 28437795 RESULT

• Poldervaart 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.

  PMID: 27810290 RESULT

Related Links

• official website of the HEART risk score

MeSH Terms

Conditions

Chest Pain; Tooth, Impacted

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Hesitance to refrain from admission and testing in patients with low scores could explain the low impact on health care costs.

Results Point of Contact

• Title: Dr. Judith Poldervaart
• Organization: University Medical Center Utrectht

j.poldervaart@umcutrecht.nl

008875 55105

Study Officials

• Arno W Hoes, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Epidemiology & General Practice and Chair, Julius Center for Health Sciences and Primary Care

Model Details: 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).

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 28, 2012
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08

Locations

NL (9)