Incremental Value of Point of Care H-FABP Testing in Primary Care Patients Suspected of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— RAPIDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826994
• Other study ID #: 13-3-015
• Secondary ID: ABR registry
• Status: Completed
• Phase: N/A
• First received: April 4, 2013
• Last updated: April 10, 2017
• Start date: September 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina Pectoris, Stable
• Angina Pectoris, Unstable
• Angina, Stable
• Angina, Unstable
• Syndrome
• Thoracic Diseases

Intervention

Device:
• heart type fatty acid binding protein testing

Locations

Country	Name	City	State
Belgium	ACHG	Leuven	Vlaams Brabant
Netherlands	BeRoEmD	Den Bosch	Brabant
Netherlands	SGE	Eindhoven	Brabant
Netherlands	HOZL	Heerlen	Limburg
Netherlands	ZIO	Maastricht	Limburg
Netherlands	Omnes	Sittard	Limburg
Netherlands	Cohesie	Venlo	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	FABPulous B.V.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity, specificity, positive and negative predictive 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. To determine influence of sex, age, duration of the complaints, and kidney function on clinical performance of heart type fatty acid binding protein testing, subgroup analysis within our study population will be performed	one and a half year
Secondary	cost-effectiveness	An economic evaluation by means of an incremental cost-effectiveness ratio will be performed. This evaluation will be performed by determination of the ratio between the difference in costs and the difference in benefits between the two strategies that are observed in this study, being the usual reference policy of the general practitioner and the reference policy that could be created when a determined algorithm combined with point of care heart type fatty acid binding protein testing would be used.	one and a half year
Secondary	definition of an algorithm towards diagnosing acute coronary syndrome and unstable angina	Predictive value of a diagnostic algorithm towards diagnosing acute coronary syndrome and unstable angina is determined, since unstable angina is a condition without rise in biomarkers, but should not be missed by a general practitioner assessing thoracic complaints	one and a half year