Acute Coronary SyndromeRAPIDANCT01826994
Incremental Value of Point of Care H-FABP Testing in Primary Care Patients Suspected of Acute Coronary Syndrome
A study testing heart type fatty acid binding protein testing in people with Acute Coronary Syndrome and Angina Pectoris, Unstable, run by Maastricht University Medical Center at 7 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Angina Pectoris, Unstable, Angina Pectoris, Stable
- What is being tested?
- heart type fatty acid binding protein testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Netherlands6 sites
BeRoEmD
's-Hertogenbosch, North Brabant, 5258KG
SGE
Eindhoven, North Brabant, 5622AB
HOZL
Heerlen, Limburg, 6411TE
ZIO
Maastricht, Limburg, 6221 BG
Omnes
Sittard, Limburg, 6135 LH
Cohesie
Venlo, Limburg, 5912 PN
About this study
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
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.
Read more
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
- Being tested
- heart type fatty acid binding protein testing
- Medical subject headings
- Acute Coronary Syndrome, Angina, Unstable, Angina, Stable, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart type fatty acid binding protein testingDevice
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | heart type fatty acid binding protein testing Receives: Device: heart type fatty acid binding protein testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one and a half year
Secondary outcomes (2)
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.
Measured: one and a half year
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
Measured: one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- FABPulous B.V.
- Responsible party
- Sponsor
- Investigators
- Geert Jan Dinant, professor, Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826994
- Sponsor's protocol ID
- 13-3-015
- Other IDs
- ABR registry
- Acronym
- RAPIDA
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2013
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25738970
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01826994
- Acronym / sponsor ID
- RAPIDA / 13-3-015
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Unstable, Angina Pectoris, Stable, Thoracic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- FABPulous B.V.
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Device: heart type fatty acid binding protein testingheart type fatty acid binding protein testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart type fatty acid binding protein testing | Device | patients |
Primary outcome
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
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
2 secondary outcomes
cost-effectiveness
Time frame: one and a half year
definition of an algorithm towards diagnosing acute coronary syndrome and unstable angina
Time frame: one and a half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 25738970Willemsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Jan Dinant, professor study chair
Maastricht University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart type fatty acid binding protein testing in people with Acute Coronary Syndrome and Angina Pectoris, Unstable, run by Maastricht University Medical Center at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: one and a half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.