Clinical trial NCT05827237: Rule Out of ACS in Primary Care Using a Decision Rule for Chest Pain Including Hs-troponin I POCT
Official title: Primary Care Decision Rule for Chest Pain Using the Marburg Heart Score and Hs-troponin I Point of Care Test to Rule Out Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chest Pain
Myocardial Infarction
Acute Coronary Syndrome
Keywords: Chest pain
Primary care
General practice
Myocardial infarction
Troponin
Point of care test
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht Universitair Medisch Centrum
name: VieCuri Medical Centre
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-04-25
Enrollment: 946
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.
Primary purpose: DIAGNOSTIC

Brief summary: 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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital referral rate for acute chest pain
timeFrame: 24 hours after inclusion
measure: Hospital referral rate for acute chest pain
timeFrame: 6 weeks after inclusion
measure: Diagnostic accuracy of the clinical decision rule
timeFrame: 24 hours after inclusion
measure: Diagnostic accuracy of the clinical decision rule
timeFrame: 6 weeks after inclusion
measure: Diagnostic accuracy of the clinical decision rule
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 6 months
measure: Adherence to the recommendations of the clinical decision rule by general practitioners (GP)
timeFrame: 24 hours after inclusion
measure: Patient reassurance measured by the State-Trait Anxiety Inventory
timeFrame: 1 week after inclusion
measure: Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners
timeFrame: 6 weeks after inclusion
measure: Diagnostic accuracy of the HEART-score
timeFrame: 6 weeks after inclusion
measure: Subgroup analyses for hospital referral rate for acute chest pain
timeFrame: 24 hours after inclusion
measure: Subgroup analyses for hospital referral rate for acute chest pain
timeFrame: 6 weeks after inclusion
measure: Subgroup analyses for diagnostic accuracy of the clinical decision rule
timeFrame: 24 hours after inclusion
measure: Subgroup analyses for diagnostic accuracy of the clinical decision rule
timeFrame: 6 weeks after inclusion
measure: Subgroup analyses for diagnostic accuracy of the clinical decision rule
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
Study officials:
affiliation: LUMC
name: Tobias Bonten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: