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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Maastricht University Medical Center
Sponsor:
Collaborator:
FABPulous B.V.
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01826994
First received: April 4, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Acute Coronary Syndrome
Angina Pectoris, Unstable
Angina Pectoris, Stable
Thoracic Diseases
Device: heart type fatty acid binding protein testing

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: one and a half year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: one and a half year ] [ Designated as safety issue: No ]
    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.

  • definition of an algorithm towards diagnosing acute coronary syndrome and unstable angina [ Time Frame: one and a half year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patients
heart type fatty acid binding protein testing
Device: heart type fatty acid binding protein testing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826994

Contacts
Contact: Robert Willemsen, MD +31433882302 robert.willemsen@maastrichtuniversity.nl

Locations
Belgium
ACHG Not yet recruiting
Leuven, Vlaams Brabant, Belgium, B-3000
Contact: Robert Willemsen, MD    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Evie van Severen, PhD         
Netherlands
BeRoEmD Not yet recruiting
Den Bosch, Brabant, Netherlands, 5258KG
Contact: Robert Willemsen, MD    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
SGE Not yet recruiting
Eindhoven, Brabant, Netherlands, 5622AB
Contact: Robert Wilemsen    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
HOZL Recruiting
Heerlen, Limburg, Netherlands, 6411TE
Contact: Robert Willemsen, MD    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
ZIO Not yet recruiting
Maastricht, Limburg, Netherlands, 6221 BG
Contact: Robert Willemsen, MD    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
Omnes Recruiting
Sittard, Limburg, Netherlands, 6135 LH
Contact: Robert Willemsen    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
Cohesie Not yet recruiting
Venlo, Limburg, Netherlands, 5912 PN
Contact: Robert Willemsen    +31433882302    robert.willemsen@maastrichtuniversity.nl   
Principal Investigator: Robert Willemsen, MD         
Sponsors and Collaborators
Maastricht University Medical Center
FABPulous B.V.
Investigators
Study Chair: Geert Jan Dinant, professor Maastricht University
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01826994     History of Changes
Other Study ID Numbers: 13-3-015, ABR registry
Study First Received: April 4, 2013
Last Updated: September 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Thoracic Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014