Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT (POB HELP)

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Acute Coronary Syndrome; Chest Pain; Myocardial Infarction

Treatments: Diagnostic Test: Clinical decision rule

Study type: Interventional

Funder types: Other

Identifiers

NCT05827237

p20.013

Details and patient eligibility

About

The goal of this clustered, diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin I point of care test in patients with chest pain in primary care.

The main questions it aims to answer are:

1. Can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset, non-traumatic chest pain in primary care? Compared to current daily practice.
2. What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?

Full description

This clustered, diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner. Practices in the intervention group will use a clinical decision rule consisting of the Marburg Heart Score and a high-sensitive troponin I point of care test to exclude acute coronary syndrome (ACS) and decide upon referral. Practices in the control group will apply usual care following local guidelines.

An independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis. Primary endpoints are ACS and Major Adverse Cardiac Events. A delayed reference standard of 6 months will be used.

For high sensitive troponin I measurement, the Siemens Atellica VTLi immunoassay analyser is used.

Enrollment: 946 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Acute chest pain
• Seen by general practitioner

Exclusion criteria

• <1 hour since onset of symptoms
• Inability to speak or understand Dutch
• Hemodynamic instability

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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946 participants in 2 patient groups

Clinical decision rule

Experimental group

Description:

Patients in whom the clinical decision rule is used to exclude acute coronary syndrome

Treatment:

Diagnostic Test: Clinical decision rule

Standard care

No Intervention group

Description:

Patients in whom the general practitioner decides upon referral following local guidelines.