Clinical trial NCT01826994: Incremental Value of Point of Care H-FABP Testing in Primary Care Patients Suspected of Acute Coronary Syndrome
Official title: Incremental Value of Heart-type Fatty Acid-Binding Protein (H-FABP) in Evaluating Patients Presenting With Symptoms Possibly Matching Acute Coronary Syndrome in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Angina Pectoris, Unstable
Angina Pectoris, Stable
Thoracic Diseases
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: FABPulous B.V.
First posted: 2013-04-09
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rationale:

Thoracic complaints, possibly due to a cardiac ischemic cause are a diagnostic challenge in general practice. When an underlying ischemic cardiac condition (AMI (acute myocardial infarction), UAP (unstable angina pectoris)) is considered, referral from general practitioner (GP) to a cardiologist has to take place. However, cardiac analysis in 80% of referred patients is negative. To optimize referral decisions of GPs, new and fast diagnostics are needed.

Objective:

To assess the incremental diagnostic value for AMI of a novel rapid PoC H-FABP-test in addition to history taking and physical examination in patients presenting in daily general practice with possible AMI. In addition the cost-effectiveness of the test will be evaluated.

Study design:

Delayed type cross-sectional diagnostic study.

Study population:

Patients presenting to the GP with any new-onset chest complaint, at time of presentation not lasting for more than 24 hours, that is considered to be of possible cardiac origin by the GP.

Intervention:

Point of care Heart Type Fatty Acid Binding Protein test (PoC H-FABP-test), added to usual care. PoC H-FABP-testing, by qualitatively measuring H-FABP in one single drop of blood obtained by finger prick, is added to normal procedures of consultation and referral decision by the GP.

Main study parameters / endpoints:

Sensitivity, specificity, positive and negative predictive value of point of care H-FABP-testing for AMI, alone as well as part of a clinical diagnostic algorithm, in patients with thoracic complaints in general practice. All outcome measures, based on using an algorithm and/or point of care H-FABP-testing, will be compared to regular diagnostic assessment by the GP without using an algorithm and/or point of care H-FABP-testing. Therefore, incremental value of H-FABP-testing and/or a diagnostic algorithm is measured.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Individual participants will experience low risk, since study participation comprehends regular care except for an extra finger prick and possibly collection of one extra venous blood sample. For this low amount of disadvantage, the participant will experience no advantage either. However, results of the study will possibly be useful for similar patients in future.


Eligibility criteria: Inclusion Criteria:

* new-onset chest complaint, considered to be of possible cardiac origin by the general practitioner
* In case of death of identified cause patients are included as well.

Exclusion Criteria:

* all attention has to be on acute support for the patient
* symptoms are present for more than 24 hours
* oral informed consent is not given during presentation
* written informed consent is refused afterwards
* a traumatic cause is present
* complaints are presented that can be regarded as a recurrence of earlier complaints with clear diagnosis in the past
* death of unidentified cause.

Primary outcomes:
measure: diagnostic value of point of care heart type fatty acid binding protein testing for acute myocardial infection, alone as well as in combination with a clinical diagnostic algorithm
timeFrame: one and a half year
Secondary outcomes:
measure: cost-effectiveness
timeFrame: one and a half year
measure: definition of an algorithm towards diagnosing acute coronary syndrome and unstable angina
timeFrame: one and a half year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: ACHG
state: Vlaams Brabant
city: Den Bosch
country: Netherlands
facility: BeRoEmD
state: Brabant
city: Eindhoven
country: Netherlands
facility: SGE
state: Brabant
city: Heerlen
country: Netherlands
facility: HOZL
state: Limburg
city: Maastricht
country: Netherlands
facility: ZIO
state: Limburg
city: Sittard
country: Netherlands
facility: Omnes
state: Limburg
city: Venlo
country: Netherlands
facility: Cohesie
state: Limburg
Study officials:
affiliation: Maastricht University
name: Geert Jan Dinant, professor
role: STUDY_CHAIR
References:
citation: Willemsen RT, Buntinx F, Winkens B, Glatz JF, Dinant GJ; 'RAPIDA'-study team. The value of signs, symptoms and plasma heart-type fatty acid-binding protein (H-FABP) in evaluating patients presenting with symptoms possibly matching acute coronary syndrome: background and methods of a diagnostic study in primary care. BMC Fam Pract. 2014 Dec 12;15:203. doi: 10.1186/s12875-014-0203-8.