No registrations found.
ID
Source
Brief title
Health condition
Acute coronary syndrome, myocardial infarction, NSTEMI
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Difference in false-positive referrals to secondary care between the intervention and control group.
2. Accuracy (specificity and sensitivity) of the decision rule for excluding CAD and ACS
Secondary outcome
1) Costs
(2) accuracy HEART-score (retrospective)
(3) quality of life
(4) (non-)adherence of GP’s to the decision rule
(5) patient reassurance
(6) accuracy of GP’s gut feeling
(7) cardiologist’s advice after consultation
Background summary
A clustered randomized controlled trial to determine the effectiveness and safety of a decision rule compared to the usual care for patients presenting with non-traumatic chest pain in primary care in the Netherlands. The decision rule is a combination of the Marburg Heart Score and a hs-troponin I point of care test. Primary end points are the safety of the decision rule (accuracy) and the effectiveness (referrals to secondary care).
Study objective
We hypothesize that by use of the decision rule, compared to usual care, the GP’s specificity will increase, following a 10% decrease in false-positive referrals. Provided that sensitivity sufficient to guarantee patient safety
Study design
Inclusion, and 1, 6 and 26 weeks after inclusion
Intervention
Clinical decision rule
Inclusion criteria
>18 years
New, non traumatic chest pain where a cardiac etiology is considered possible
Exclusion criteria
Hemodynamic instability
<1 hour since onset of pain
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9525 |
| Other | METC Leiden-Den Haag-Delft (METC-LDD) : p20.013 |