Improving the Referral of Patients With Chest Pain

Not Applicable

Terminated

• Conditions: Myocardial Infarction; Acute Coronary Syndrome; Chest Pain
• Interventions: Diagnostic Test: General Practitioner diagnosis with Heart score

• Registration Number: NCT03115190
• Lead Sponsor: VieCuri Medical Centre

Brief Summary

Rationale: This study aims to aid the general practitioner (GP) in the diagnostic dilemma of chest pain patients. Patients with acute coronary syndrome (ACS) should be referred to the hospital promptly, though referring all patients with chest pain is not feasible, as up to 80% of the patients with chest pain in the primary care do not have ACS.

Objective: The primary objective is to refer patients who contact the out-of-hours GP cooperation (GPC) with suspicion of ACS more accurately with a hypothesized reduction of 10% in unnecessary referrals.

Study design: This study is a prospective, observational, prevalence-based cohort study within the standard care of ACS patients.

Study population: All patients with chest pain, or other complaints suspect of ACS, will be included in which the GP at the GPC is in need of further diagnostics to come to a decision of referral. The follow-up will be a registry of all patients with suspected ACS referred to the emergency department (ED). Patients with typical complaints of ACS, and thus a high suspicion, will be excluded and referred promptly.

Intervention: Triage nurses working at the GPC will receive specific ACS training. Patients who arrive at the GPC with non-typical chest pain, will be screened for enrolment within the study. The GP evaluates patients using the Heart score, this includes electrocardiogram recording and point of care (POC) troponin testing. With the Heart score the GP can make an informed decision to refer the patient to the ED.

To evaluate the intervention a registry of all patients referred to the ED with suspected ACS will be compared to a baseline registry performed from the 1st of September 2015 until the 1st of March 2016. Patients not referred to the ED, will have a (standard) high-sensitivity troponin and a POC troponin as follow-up at least four hours (up to 24 hours) after first measurement.

The burden and risks associated with participation, benefit and group relatedness: Patients enrolled within this study will receive a finger stick blood test and electrocardiogram recording at the GPC and a finger stick blood test and a venous blood test at least four hours after first troponin measurement. We may follow-up by telephone if we can not obtain the required information from medical records. We expect no adverse events and there are no expected risks associated with this protocol. We expect patients with ACS to be referred more accurately and more promptly to the ED and thus lowering risks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2017-04-18
• Primary Completion: 2017-11-01
• Study Completion: 2018-11-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All patients with chest pain or other complaints suspect of acute coronary syndrome (ACS) can be included in which the general practitioner is in need of further diagnostics to come to a decision of referral.

All patients referred to the emergency department (ED) with suspected ACS will be included to evaluate the appropriateness of referral.

Exclusion Criteria

• Patients younger than 18 years
• Patients in which a typical history and/or physical examination requires immediate referral; high suspicion of ACS
• Patients in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.

The baseline of patients seen at the ED will not exclude any patients referred with suspected ACS.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
General practitioner diagnosis with Heart score	General Practitioner diagnosis with Heart score	Patients with chest pain who are reviewed by the general practitioner (GP) at the GP cooperation will be evaluated with the Heart score to support the GP with the diagnosis.

Primary Outcome Measures

Name	Time	Method
Suspected diagnosis	30 days	The primary outcome measure is a more accurate referral of patients with suspected acute coronary syndrome (ACS) to the cardiac emergency department and thus the concordance of suspected ACS and the actual diagnosis. The endpoint will be compared to the baseline registry that has been executed from 1st of September 2015 until 1st of March 2016.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	30 days, 6 months and 1 year	Combination endpoint of: mortality and any ischemic event (ST-elevated myocardial infarction, non-ST-elevated myocardial infarction, (Unstable)Angina Pectoris, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Resuscitation)

Trial Locations

Locations (1)

VieCuri Medical Center; 🇳🇱 Venlo, Netherlands