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

Myocardial Infarction Clinical Trial

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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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05827237
• Other study ID #: p20.013
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 946
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Infarction
• Myocardial Infarction
• Syndrome

Intervention

Diagnostic Test:
• Clinical decision rule
Clinical decision rule for acute chest pain, consisting of the Marburg Heart Score (5 questions) combined with a high-sensitive troponin I point of care test

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid Holland

Sponsors (4)

Lead Sponsor	Collaborator
Leiden University Medical Center	Maastricht Universitair Medisch Centrum, VieCuri Medical Centre, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital referral rate for acute chest pain	hospital referral rate for acute chest pain compared between intervention and control group	24 hours after inclusion
Primary	Hospital referral rate for acute chest pain	hospital referral rate for acute chest pain compared between intervention and control group	6 weeks after inclusion
Primary	Diagnostic accuracy of the clinical decision rule	Diagnostic accuracy (i.e. sensitivity, negative predictive value) for Acute Coronary Syndrome (ACS) and major adverse cardiac events (MACE).; MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	24 hours after inclusion
Primary	Diagnostic accuracy of the clinical decision rule	Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE); MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	6 weeks after inclusion
Primary	Diagnostic accuracy of the clinical decision rule	Diagnostic accuracy (i.e. sensitivity, negative predictive value) for ACS and major adverse cardiac events (MACE); MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	6 months after inclusion
Secondary	Cost-effectiveness	A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire)	6 months
Secondary	Adherence to the recommendations of the clinical decision rule by general practitioners (GP)	Percentage of general practitioners following and deferring from the clinical decision rule, by comparing the GP's policy with the recommendations of the decision rule.	24 hours after inclusion
Secondary	Patient reassurance measured by the State-Trait Anxiety Inventory	Reassurance of patients, using the State-Trait Anxiety Inventory after the index consultation.; State-Trait Anxiety Inventory: consisting of 40 self-report items on a 4-point Likert scale (min. 20- max. 80 points). Higher scores are correlated with higher levels of anxiety.; Compared between intervention and control group.	1 week after inclusion
Secondary	Diagnostic accuracy of the gut feeling/ presence of a sense of alarm from general practitioners	Diagnostic accuracy (i.e. sensitivity, negative predictive value) of general practitioner's gut feeling for Acute Coronary Syndrome and major adverse cardiac events (MACE). Using the Gut Feeling Questionnaire (GFC).; The questionnaire consists of 11 items. The items use a 5-point Likert scale: completely disagree to completely agree. Items 1 and 11 are the same and ask the physician about their gut feeling: alarm vs reassuring.; A high score indicates a sense of alarm; (From Barais M, Fossard E, Dany A, et al. Accuracy of the general practitioner's sense of alarm when confronted with dyspnoea and/or chest pain: a prospective observational study. BMJ Open. 2020;10(2):e03434)	6 weeks after inclusion
Secondary	Diagnostic accuracy of the HEART-score	Retrospectively for all patient with an ECG available for the occurrence of Acute Coronary Syndrome (ACS) and MACE.; HEART-score assigning 0, 1 or 2 points to patient history, ECG abnormalities, Age, Cardiovascular risk factors and troponin. Lower score (0-3) indicates low risk for acute cardiac event.; MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	6 weeks after inclusion
Secondary	Subgroup analyses for hospital referral rate for acute chest pain	Subgroups are classified by; sex; region (Leiden, Maastricht, Venlo); socio-economic status (using postal-code); duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)	24 hours after inclusion
Secondary	Subgroup analyses for hospital referral rate for acute chest pain	Subgroups are classified by; sex; region (Leiden, Maastricht, Venlo); socio-economic status (using postal-code); duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours)	6 weeks after inclusion
Secondary	Subgroup analyses for diagnostic accuracy of the clinical decision rule	Subgroups are classified by; sex; region (Leiden, Maastricht, Venlo); socio-economic status (using postal-code); duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours); For the occurrence of ACS and MACE. MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	24 hours after inclusion
Secondary	Subgroup analyses for diagnostic accuracy of the clinical decision rule	Subgroups are classified by; sex; region (Leiden, Maastricht, Venlo); socio-economic status (using postal-code); duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours); For the occurrence of ACS and MACE. MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	6 weeks after inclusion
Secondary	Subgroup analyses for diagnostic accuracy of the clinical decision rule	Subgroups are classified by; sex; region (Leiden, Maastricht, Venlo); socio-economic status (using postal-code); duration of symptoms (<2 hours, 2-6 hours, 6-12 hours, >12 hours, >24 hours); For the occurrence of ACS and MACE. MACE is defined as a combined endpoint of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.	6 months after inclusion

External Links

•   Original registration on www.NTR.nl before start of the study
•   Up to date information about the study for patients and general practitioners (Dutch)