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

Sponsor

Leiden University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05827237

Collaborator

Maastricht Universitair Medisch Centrum (Other), VieCuri Medical Centre (Other), ZonMw: The Netherlands Organisation for Health Research and Development (Other)

1,500

Enrollment

Location

Arms

34.4

Anticipated Duration (Months)

43.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.
What is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding ACS and MACE at 6 weeks and 6 months?

Condition or Disease	Intervention/Treatment	Phase
Chest Pain Myocardial Infarction Acute Coronary Syndrome	Diagnostic Test: Clinical decision rule	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Aug 18, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinical decision rule Patients in whom the clinical decision rule is used to exclude acute coronary syndrome	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
No Intervention: Standard care Patients in whom the general practitioner decides upon referral following local guidelines.

Arm

Intervention/Treatment

Experimental: Clinical decision rule

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

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

No Intervention: Standard care

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

Outcome Measures

Primary Outcome Measures

Hospital referral rate for acute chest pain [24 hours after inclusion]
hospital referral rate for acute chest pain compared between intervention and control group
Hospital referral rate for acute chest pain [6 weeks after inclusion]
hospital referral rate for acute chest pain compared between intervention and control group
Diagnostic accuracy of the clinical decision rule [24 hours after inclusion]
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.
Diagnostic accuracy of the clinical decision rule [6 weeks after inclusion]
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.
Diagnostic accuracy of the clinical decision rule [6 months after inclusion]
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.

Secondary Outcome Measures

Cost-effectiveness [6 months]
A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire)
Percentage of general practitioners following and deferring from the clinical decision rule [24 hours after inclusion]
Adherence to the recommendations of the clinical decision rule by general practitioners (GP), by comparing the GP's policy with the recommendations of the decision rule.
Patient reassurance measured by the State-Trait Anxiety Inventory [1 week after inclusion]
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.
Diagnostic accuracy of the presence of a sense of alarm from general practitioners [6 weeks after inclusion]
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)
Diagnostic accuracy of the HEART-score [6 weeks after inclusion]
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.
Subgroup analyses for hospital referral rate for acute chest pain [24 hours after inclusion]
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)
Subgroup analyses for hospital referral rate for acute chest pain [6 weeks after inclusion]
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)
Subgroup analyses for diagnostic accuracy of the clinical decision rule [24 hours after inclusion]
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.
Subgroup analyses for diagnostic accuracy of the clinical decision rule [6 weeks after inclusion]
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.
Subgroup analyses for diagnostic accuracy of the clinical decision rule [6 months after inclusion]
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.