Acute Coronary Syndrome, Chest Pain, Myocardial Infarction
Conditions
Keywords
Chest pain, Primary care, General practice, Myocardial infarction, Troponin, Point of care test
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.
Interventions
DIAGNOSTIC_TESTClinical 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
Sponsors
Maastricht Universitair Medisch Centrum
VieCuri Medical Centre
ZonMw: The Netherlands Organisation for Health Research and Development
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A clustered randomized controlled trial in which general practices are randomized to the intervention- or control group in 2:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital referral rate for acute chest pain | 24 hours 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 gut feeling/ 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) |
| Cost-effectiveness | 6 months | A trial-based cost analysis and a cost-utility analysis (costs per QALY, assessed using the EQ-5D-5L questionnaire) |
| 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 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. |
| 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. |
| Adherence to the recommendations of the clinical decision rule by general practitioners (GP) | 24 hours after inclusion | 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. |
Countries
Netherlands
Outcome results
None listed