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

NCT ID: NCT01826994

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients

heart type fatty acid binding protein testing

Group Type: OTHER

heart type fatty acid binding protein testing

Intervention Type: DEVICE

Interventions

heart type fatty acid binding protein testing

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FABPulous B.V.

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geert Jan Dinant, professor

Role: STUDY_CHAIR

Maastricht University

Locations

ACHG

Leuven, Vlaams Brabant, Belgium

HOZL

Heerlen, Limburg, Netherlands

ZIO

Maastricht, Limburg, Netherlands

Omnes

Sittard, Limburg, Netherlands

Cohesie

Venlo, Limburg, Netherlands

BeRoEmD

's-Hertogenbosch, North Brabant, Netherlands

SGE

Eindhoven, North Brabant, Netherlands

Countries

Belgium; Netherlands

References

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.

Reference Type: DERIVED

PMID: 25738970 (View on PubMed)

Other Identifiers

ABR registry

Identifier Type: REGISTRY

Identifier Source: secondary_id

13-3-015

Identifier Type: -

Identifier Source: org_study_id