Myocardial InfarctionNCT02723851
Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects
An observational study of Myocardial Infarction, run by Corsens Medical LTD.
Trial summary
Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Corsens
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2017
- Phase
- Observational
- 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
Study population: Patients diagnosed with ST-elevation acute MI will be recruited to the study. Additional data that was already recorded in previous study from non-MI patients hospitalized for routine elective catheterization will be used.
Who may be able to join
- Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.
- Male or female subjects aged 18 years or more (with no upper limit), of any race.
- Subjects willing to participate as evidenced by signing the written informed consent.
Who cannot join
- Obese patients with BMI>35.
- Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.
- Patients after coronary artery bypass grafting
- Unstable hemodynamic condition.
- Patient that can't or do not wish to sign the Inform Consent Form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects
Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.
Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection
- Conditions
- Myocardial Infarction
- Being tested
- Corsens
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorsensDevice
Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). Measurements will not affect the treatment provided to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Acute MI patients | Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). Receives: Device: Corsens | |
| Non-MI patients | Corsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). Receives: Device: Corsens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety
To verify the safety of the Corsens technology while use for myocardial infarction detection.
Measured: 1 day
Secondary outcomes (1)
To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsens Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugenia Nikolsky, Prof., Principal investigator, Rambam Medical Center, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723851
- Sponsor's protocol ID
- CS-COP-1
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects
- ClinicalTrials.gov ID
- NCT02723851
- Acronym / sponsor ID
- CS-COP-1
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Corsens Medical LTDIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Mar 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.
Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.
Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute MI patients | – | Device: CorsensCorsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). |
| Non-MI patients | – | Device: CorsensCorsens Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with ST-elevation acute MI will be recruited to the study. Additional data that was already recorded in previous study from non-MI patients hospitalized for routine elective catheterization will be used.
Key inclusion criteria (3 listed)
- Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.
- Male or female subjects aged 18 years or more (with no upper limit), of any race.
- Subjects willing to participate as evidenced by signing the written informed consent.
Key exclusion criteria (5 listed)
- Obese patients with BMI>35.
- Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.
- Patients after coronary artery bypass grafting
- Unstable hemodynamic condition.
- Patient that can't or do not wish to sign the Inform Consent Form
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 |
|---|---|---|
| CorsensRecording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). Measurements will not affect the treatment provided to the patients. | Device | Acute MI patients, Non-MI patients |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety
Time frame: 1 day
To verify the safety of the Corsens technology while use for myocardial infarction detection.
1 secondary outcome
To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- 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.
Eugenia Nikolsky, Prof. principal investigator
Rambam Medical Center, Haifa Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Corsens Medical LTD.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr. (+972-52-2824966, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2016.