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

NCT01826994 | Completed DMC

• 2 other identifiers: 13-3-015ABR registry
• Study Type: interventional
• Target: 303
• Locations: 2 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cost-effectiveness

  one and a half year

• definition of an algorithm towards diagnosing acute coronary syndrome and unstable angina

  one and a half year

Study Arms (1)

patients

OTHER

heart type fatty acid binding protein testing

Device: heart type fatty acid binding protein testing

Interventions

heart type fatty acid binding protein testing DEVICE

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• FABPulous B.V.: collaborator

Study Sites (7)

ACHG

Leuven, Vlaams Brabant, B-3000, Belgium

Location

HOZL

Heerlen, Limburg, 6411TE, Netherlands

Location

ZIO

Maastricht, Limburg, 6221 BG, Netherlands

Location

Omnes

Sittard, Limburg, 6135 LH, Netherlands

Location

Cohesie

Venlo, Limburg, 5912 PN, Netherlands

Location

BeRoEmD

's-Hertogenbosch, North Brabant, 5258KG, Netherlands

Location

SGE

Eindhoven, North Brabant, 5622AB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 25738970 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases

Study Officials

• Geert Jan Dinant, professor

  Maastricht University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

BE (1); NL (6)