Trial Outcomes & Findings for Postoperative Acute Myocardial Ischemic Injury (NCT NCT02993263)

NCT ID: NCT02993263

Last Updated: 2022-01-11

Results Overview

Accuracy of VectraplexECG System with CEB

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

323 participants

Primary outcome timeframe

1 minute to complete the test

Results posted on

2022-01-11

Participant Flow

Recruitment process started by screening patients who are scheduled for non cardiac surgery. These patients are approached during their anesthesia clearance visit.

Open label study

Participant milestones

Participant milestones
Measure
Noncardiac Surgery
VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Overall Study
STARTED
323
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
323

Reasons for withdrawal

Reasons for withdrawal
Measure
Noncardiac Surgery
VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Overall Study
Equipment Software failed and results were lost.
323

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Noncardiac Surgery
n=323 Participants
VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Age, Continuous
62.9 years
STANDARD_DEVIATION 9.3 • n=323 Participants
Sex: Female, Male
Female
164 Participants
n=323 Participants
Sex: Female, Male
Male
159 Participants
n=323 Participants

PRIMARY outcome

Timeframe: 1 minute to complete the test

Population: Data were not collected, because of the malfunction of the equipment software failed.

Accuracy of VectraplexECG System with CEB

Outcome measures

Outcome data not reported

Adverse Events

Noncardiac Surgery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler, MD

Cleveland Clinic

Phone: 216-444-9400

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place