Myocardial InfarctionNCT02993263
Postoperative Acute Myocardial Ischemic Injury
A study testing VectraplexECG System with CEB® in people with Myocardial Infarction, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG System for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- VectraplexECG System with CEB®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- ≥ 45 years old.
- Anticipated hospitalization of at least two nights.
Who cannot join
- Inadequate ECGs, based on an initial 10-second trace, as defined by:
- wandering baseline
- excessive noise
- ventricular ectopy
- pacer spikes or
- lead placement error
Show all 12Show fewer
- Atrial fibrillation.
- Average heart rate exceeding 90 beats/minute.
- Evidence of previous myocardial infarction:
- Pathologic Q waves (≥0.04 sec) and/or
- Pathologic findings of a healed or healing MI and/or
- Evidence from an imaging study of a region of loss of viable myocardium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG System for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery.
A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the post-anesthesia care unit.
Read more
On the first, second and third post operative morning a 10 second CEB dynamic sequence will be recorded. Blood will be sampled for troponin as well.
On the first, second and third post operative afternoons a 10 second CEB dynamic sequence will be recorded.
The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will continue as long as the patient remains hospitalized.
- Conditions
- Myocardial Infarction
- Being tested
- VectraplexECG System with CEB®
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VectraplexECG System with CEB®Device
The device will be used after noncardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Noncardiac surgery | Other | VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively Receives: Device: VectraplexECG System with CEB® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy of VectraplexECG System with CEB
Measured: 1 minute to complete the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completion14 May 2018
- Study completion31 Dec 2018
Why it stopped: The study was withdrawn as there was an ECG equipment and software malfunction. There is no results for this study because of the equipment malfunction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sessler, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993263
- Sponsor's protocol ID
- 15-1556
- Status last verified
- Dec 2021
- First submitted
- 18 Jul 2016
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
- ClinicalTrials.gov ID
- NCT02993263
- Acronym / sponsor ID
- 15-1556
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was withdrawn as there was an ECG equipment and software malfunction. There is no results for this study because of the equipment malfunction.
- Enrolment
- 323 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to estimate the sensitivity and specificity of the VectraplexECG System for detecting acute myocardial ischemic injury, including acute myocardial infarctions after major non-cardiac surgery.
A 10 second CEB dynamic sequence recording will be obtained immediately after surgery in the post-anesthesia care unit.
On the first, second and third post operative morning a 10 second CEB dynamic sequence will be recorded. Blood will be sampled for troponin as well.
On the first, second and third post operative afternoons a 10 second CEB dynamic sequence will be recorded.
The morning 10 second CEB dynamic sequence and blood draw for troponin will continue as long as the patient remains hospitalized. The afternoon 10 second CEB dynamic sequence will continue as long as the patient remains hospitalized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noncardiac surgery | Other | Device: VectraplexECG System with CEB®VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent.
- ≥ 45 years old.
- Anticipated hospitalization of at least two nights.
Key exclusion criteria (12 listed)
- Inadequate ECGs, based on an initial 10-second trace, as defined by:
- Atrial fibrillation.
- Average heart rate exceeding 90 beats/minute.
- Evidence of previous myocardial infarction:
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 |
|---|---|---|
| VectraplexECG System with CEB®The device will be used after noncardiac surgery | Device | Noncardiac surgery |
Primary outcome
Accuracy
Time frame: 1 minute to complete the test
Accuracy of VectraplexECG System with CEB
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Sessler, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VectraplexECG System with CEB® in people with Myocardial Infarction, run by The Cleveland Clinic at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy (time frame: 1 minute to complete the test). 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 11 Jan 2022.