Chest PainRELF IIaNCT02983396
The Accuracy of the Mini RELF Device for the Diagnosis of an Acute Coronary Artery Occlusion.
A study testing Diagnostic accuracy of Mini Relf Device in people with Chest Pain and ST Elevation Myocardial Infarction, run by University Ghent at 3 sites in Belgium.
Trial summary
Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary syndromes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Pain, ST Elevation Myocardial Infarction
- What is being tested?
- Diagnostic accuracy of Mini Relf Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesBelgium
- Study dates
- 18 Nov 2016to 19 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have an appointment for an elective coronary angioplasty.
Who cannot join
- Patients with coronary artery bypass grafts.
- Patients with implanted pacemaker or ICD.
- Patients who remain hospitalized until the planned angioplasty.
- Patient who are unfamiliar with use of smart phone. The test question "did you use by yourself a smart phone to make a telephone call in the last 4 weeks" should be answered by yes.
- Patients who cannot tolerate repetitive applications of standard skin electrodes on the chest.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, 8000
University Hospital Ghent
Ghent, 9000
AZ Sint Nikolaas
Sint-Niklaas, 9100
About this study
Official title: The Accuracy of the Mini RELF Device Relative to the 12 Lead ECG for the Diagnosis of an Acute Coronary Artery Occlusion in Patients With Coronary Artery Disease.
Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary syndromes. The Mini RELF device is a hand held self applicable device intended to detect on an individual basis an elevation of the ST segment that is indicative for an acute coronary occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is self-applied on a daily basis by patients with coronary artery disease.
Read the detailed description
The increasing availability of small hand held medical devices is a novel opportunity to develop a tool that guides patients through the decision-taking processes of seeking medical attendance during symptoms suggestive of acute myocardial infarction. The cornerstone of early diagnosis, risk stratification and treatment is the presence of ST segment elevation during symptoms suggestive of STEMI. Therefore, a hand held medical device that can detect ST segment elevation with high sensitivity and specificity could be a breakthrough in the further reduction of fatality from acute myocardial infarction. A number of conditions of the tool must be fulfilled to allow save use with a low threshold in the general population. Most important is the accuracy to detect any new ST segment elevation related to an acute artery occlusion. For more than 30 years the 12-lead ECG is the gold standard for detection of ST elevation. However, acute coronary occlusions of a posterior or lateral segment are not always detected by the gold standard. Moreover, in the very early phase of acute coronary occlusion, the accuracy 12 lead ECG is inadequate.
In a previous study "Diagnostic accuracy of a novel method for detection of acute transmural myocardial ischemia based upon a self-applicable 3-lead configuration" the investigators developed and validated a sensitive and specific 3-lead ECG method (RELF method). The method includes a new lead configuration and a new algorithm to analyze the ECG recordings based on an intra-individual comparisons of ST levels. In summary, a 3-lead recording from a healthy subject or from a patient with an acute coronary occlusion is compared automatically to one or more previous reference recordings from the same individual. The individualized ST shift is used as a decision variable to detect or reject an acute coronary artery occlusion. The RELF method was more accurate then the simultaneously applied 12-lead ECG which had a lower sensitivity and specificity. In that study all recordings were performed by a sophisticated ECG recording system. The RELF method is designed to be applicable also by small hand held ECG devices such as the self-applicable Mini RELF device.
In the current study the investigators aim to evaluate the accuracy of Mini RELF device relative to the 12 lead ECG when the device is self-applied on a daily basis by patients with coronary artery disease. In a parallel study (RELF IIb) the investigators aim to evaluate the specificity of the RELF method when it is self-applied by healthy subjects who are representative for future users of the device.
- Conditions
- Chest Pain, ST Elevation Myocardial Infarction
- Being tested
- Diagnostic accuracy of Mini Relf Device
- Keywords
- RELF method, Medical device, Admission delay
- Medical subject headings
- Chest Pain, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic accuracy of Mini Relf DeviceDevice
Evaluation of the Mini Relf Device when it is applied on daily basis at home and during coronary angioplasty at 60 second acute coronary occlusion angioplasty
| Study group | Role | What they receive |
|---|---|---|
| no transmural ischemia (NTI) and transmural ischemia (TI) | Experimental | Case cross-over from "no transmural ischemia (NTI)" to "transmural ischemia at 60 s coronary occlusion during elective coronary angioplasty (TI)"
Comparison of diagnostic accuracy of standard 12-lead ECG versus Mini RELF device for detection of transmural ischemia. Receives: Device: Diagnostic accuracy of Mini Relf Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-2 (The orthonormalized ST shift vector magnitude)
The sensitivity and specificity of the orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.
Measured: One week after coronary angioplasty
Secondary outcomes (3)
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-3
The sensitivity and specificity of the intraindividual orthonormalized ST shift vector magnitude
Measured: One week after coronary angioplasty
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-1 (The gender specific orthonormalized ST vector magnitude) and of Modus RELF-3 (The intra-individual orthonormalized ST shift vector magnitude).
The sensitivity and specificity of the gender specific orthonormalized ST vector magnitude and the intra-individual orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.
Measured: One week after coronary angioplasty
Number of participants with symptoms of contact dermatitis in the thoracic device-skin contact area.
Contact dermatitis is defined by the clinical presence of redness or itching or blistering delineated in the thoracic device-skin contact area during at least one of the three clinical visits in the study participation period.
Measured: One week after coronary angioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start18 Nov 2016
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
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 Chest PainStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Gheeraert, Professor, Study chair, University Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983396
- Sponsor's protocol ID
- UniversityGhent
- Acronym
- RELF IIa
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2016
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Van Heuverswyn F, De Buyzere M, Coeman M, De Pooter J, Drieghe B, Duytschaever M, Gevaert S, Kayaert P, Vandekerckhove Y, Voet J, El Haddad M, Gheeraert P. Feasibility and performance of a device for automatic self-detection of symptomatic acute coronary artery occlusion in outpatients with coronary artery disease: a multicentre observational study. Lancet Digit Health. 2019 Jun;1(2):e90-e99. doi: 10.1016/S2589-7500(19)30026-3. Epub 2019 May 23.
PubMed 33323233
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of the Mini RELF Device Relative to the 12 Lead ECG for the Diagnosis of an Acute Coronary Artery Occlusion in Patients With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT02983396
- Acronym / sponsor ID
- RELF IIa / UniversityGhent
- Conditions
- Chest Pain, ST Elevation Myocardial Infarction
- Keywords
- RELF method, Medical device, Admission delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 6 Dec 2016 (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.
Patient delay in seeking medical attendance for symptoms of acute ST elevation myocardial infarction (STEMI) is the major obstacle to reduce the current mortality from acute coronary syndromes. The Mini RELF device is a hand held self applicable device intended to detect on an individual basis an elevation of the ST segment that is indicative for an acute coronary occlusion. The investigators aim to evaluate the accuracy of Mini RELF device when it is self-applied on a daily basis by patients with coronary artery disease.
Detailed description
The increasing availability of small hand held medical devices is a novel opportunity to develop a tool that guides patients through the decision-taking processes of seeking medical attendance during symptoms suggestive of acute myocardial infarction. The cornerstone of early diagnosis, risk stratification and treatment is the presence of ST segment elevation during symptoms suggestive of STEMI. Therefore, a hand held medical device that can detect ST segment elevation with high sensitivity and specificity could be a breakthrough in the further reduction of fatality from acute myocardial infarction. A number of conditions of the tool must be fulfilled to allow save use with a low threshold in the general population. Most important is the accuracy to detect any new ST segment elevation related to an acute artery occlusion. For more than 30 years the 12-lead ECG is the gold standard for detection of ST elevation. However, acute coronary occlusions of a posterior or lateral segment are not always detected by the gold standard. Moreover, in the very early phase of acute coronary occlusion, the accuracy 12 lead ECG is inadequate.
In a previous study "Diagnostic accuracy of a novel method for detection of acute transmural myocardial ischemia based upon a self-applicable 3-lead configuration" the investigators developed and validated a sensitive and specific 3-lead ECG method (RELF method). The method includes a new lead configuration and a new algorithm to analyze the ECG recordings based on an intra-individual comparisons of ST levels. In summary, a 3-lead recording from a healthy subject or from a patient with an acute coronary occlusion is compared automatically to one or more previous reference recordings from the same individual. The individualized ST shift is used as a decision variable to detect or reject an acute coronary artery occlusion. The RELF method was more accurate then the simultaneously applied 12-lead ECG which had a lower sensitivity and specificity. In that study all recordings were performed by a sophisticated ECG recording system. The RELF method is designed to be applicable also by small hand held ECG devices such as the self-applicable Mini RELF device.
In the current study the investigators aim to evaluate the accuracy of Mini RELF device relative to the 12 lead ECG when the device is self-applied on a daily basis by patients with coronary artery disease. In a parallel study (RELF IIb) the investigators aim to evaluate the specificity of the RELF method when it is self-applied by healthy subjects who are representative for future users of the device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no transmural ischemia (NTI) and transmural ischemia (TI) | Experimental | Device: Diagnostic accuracy of Mini Relf DeviceCase cross-over from "no transmural ischemia (NTI)" to "transmural ischemia at 60 s coronary occlusion during elective coronary angioplasty (TI)" Comparison of diagnostic accuracy of standard 12-lead ECG versus Mini RELF device for detection of transmural ischemia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have an appointment for an elective coronary angioplasty.
Key exclusion criteria (5 listed)
- Patients with coronary artery bypass grafts.
- Patients with implanted pacemaker or ICD.
- Patients who remain hospitalized until the planned angioplasty.
- Patient who are unfamiliar with use of smart phone. The test question "did you use by yourself a smart phone to make a telephone call in the last 4 weeks" should be answered by yes.
- Patients who cannot tolerate repetitive applications of standard skin electrodes on the chest.
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 |
|---|---|---|
| Diagnostic accuracy of Mini Relf DeviceEvaluation of the Mini Relf Device when it is applied on daily basis at home and during coronary angioplasty at 60 second acute coronary occlusion angioplasty | Device | no transmural ischemia (NTI) and transmural ischemia (TI) |
Primary outcome
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-2 (The orthonormalized ST shift vector magnitude)
Time frame: One week after coronary angioplasty
The sensitivity and specificity of the orthonormalized ST shift vector magnitude during occlusion compared to the sensitivity and specificity of the 12 lead ECG.
3 secondary outcomes
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-3
Time frame: One week after coronary angioplasty
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-1 (The gender specific orthonormalized ST vector magnitude) and of Modus RELF-3 (The intra-individual orthonormalized ST shift vector magnitude).
Time frame: One week after coronary angioplasty
Number of participants with symptoms of contact dermatitis in the thoracic device-skin contact area.
Time frame: One week after coronary angioplasty
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 10 Dec 2021.
- Derived from this study: PubMed 33323233Van Heuverswyn F, De Buyzere M, Coeman M, De Pooter J, Drieghe B, Duytschaever M, Gevaert S, Kayaert P, Vandekerckhove Y, Voet J, El Haddad M, Gheeraert P. Feasibility and performance of a device for automatic self-detection of symptomatic acute coronary artery occlusion in outpatients with coronary artery disease: a multicentre observational study. Lancet Digit Health. 2019 Jun;1(2):e90-e99. doi: 10.1016/S2589-7500(19)30026-3. Epub 2019 May 23.
- Individual participant dataSharing planned: No
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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.
Peter Gheeraert, Professor study chair
University Ghent, Belgium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic accuracy of Mini Relf Device in people with Chest Pain and ST Elevation Myocardial Infarction, run by University Ghent at 3 sites in Belgium.
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 1 inclusion and 5 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 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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?
The accuracy (Area under the sensitivity-aspecificity curve) of Modus RELF-2 (The orthonormalized ST shift vector magnitude) (time frame: One week after coronary angioplasty). 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 NCT02983396, 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 10 Dec 2021.