The goals of our study are: 1) to evaluate the performance of a single hs-troponin measurement using universal and sex-specific cut-off values; 2) to evaluate whether embedding hs-troponin in a clinical risk score (HEART, INTERCHEST, Marburg Heart…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic test characteristics (sensitivity, specificity, accuracy, NPV and
PPV) for the occurrence of major adverse cardiovascular events (MACE) within 6
weeks of the index consultation.
Secondary outcome
-
Background summary
General practitioners (GPs) frequently assess patients with chest pain. The
challenge in primary care is to make the distinction between acute cardiac
conditions versus far more common, non-urgent diagnoses in an unselected
case-mix of patients, with limited resources and time constraints. All while
being fully aware that symptom characteristics and signs are at best a mediocre
indicator in both male and female patients. Currently, both misdiagnosis and
over-testing are key concerns, and standardized diagnostic strategies may help
GPs to balance these risks. We propose that a recently developed fingerstick
test for high-sensitivity(hs) troponin may present a breakthrough in this
regard for safe rule out of acute cardiac conditions, particularly when
integrated with a pretest probability assessment, using clinical risk scores.
Study objective
The goals of our study are: 1) to evaluate the performance of a single
hs-troponin measurement using universal and sex-specific cut-off values; 2) to
evaluate whether embedding hs-troponin in a clinical risk score (HEART,
INTERCHEST, Marburg Heart Score) will further improve performance, in terms of
increased efficiency without compromising safety; 3) to evaluate experiences
and preferences of GPs, triage nurses and patient participants in regards to
the evaluated risk stratification tools; 4) to construct a chest pain decision
rule that is safe, efficient, fit for use and implementable in out-of-hours
primary care.
Central hypothesis
Evaluation of acute chest pain can be improved when GPs are provided with
modern decision support tools
Study design
1) Comparative Diagnostic accuracy study
2) Qualitative study using interviews and focus group meetings
Study burden and risks
The collection of relevant patient information will take additional time during
the consultation, estimated at 10-15 minutes. The measurement of hs-troponin
requires a finger stick blood sample, which brings little to no additional risk
to the patient. The patient will experience a short sting when a few droplets
are collected. The clinical course (i.e. referral and/or treatment) will be
decided by the clinical judgement of the GP.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Age 18 years or older
• Presence of chest pain at time of consultation, where a cardiac etiology is
considered possible
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Hemodynamic instability
• Chest trauma preceding chest pain
• Not able to provide informed consent
• Not registered with a GP in the Netherlands
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL82428.000.22 |