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The study was withdrawn as there was an ECG equipment and software malfunction.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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noncardiac surgery | Other | VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VectraplexECG System with CEB® | Device | The device will be used after noncardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Accuracy of VectraplexECG System with CEB | 1 minute to complete the test |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sessler, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Open label study
Recruitment process started by screening patients who are scheduled for non cardiac surgery. These patients are approached during their anesthesia clearance visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Noncardiac Surgery | VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Noncardiac Surgery | VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy | Accuracy of VectraplexECG System with CEB | Data were not collected, because of the malfunction of the equipment software failed. | Posted | 1 minute to complete the test |
|
|
30 days
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Noncardiac Surgery | VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland Clinic | 216-444-9400 | sesslers@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |