Postoperative Acute Myocardial Ischemic Injury

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02993263
• Collaborator: (none)
• Enrollment: 323
• Location: 1
• Arm: 1
• Actual Duration (Months): 35
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Device: VectraplexECG System with CEB®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Detection and Prediction of Postoperative Acute Myocardial Ischemic Injury/Infarction by the VectraplexECG System With CEB®
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: May 14, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Noncardiac surgery VectraplexECG System with CEB® will be recorded after surgery and on day 1, 2 and 3 post operatively	Device: VectraplexECG System with CEB®; The device will be used after noncardiac surgery

Outcome Measures

Primary Outcome Measures

1. Accuracy [1 minute to complete the test]

   Accuracy of VectraplexECG System with CEB

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Written informed consent.

2. ≥ 45 years old.

3. Anticipated hospitalization of at least two nights.

Exclusion Criteria:

1. Inadequate ECGs, based on an initial 10-second trace, as defined by:

• wandering baseline

• excessive noise

• ventricular ectopy

• pacer spikes or

• lead placement error

1. Atrial fibrillation.

2. Average heart rate exceeding 90 beats/minute.

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Daniel Sessler, M.D., The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 1, 2017

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02993263
• Other Study ID Numbers: 15-1556
• First Posted: Dec 15, 2016
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Recruitment Details	Recruitment process started by screening patients who are scheduled for non cardiac surgery. These patients are approached during their anesthesia clearance visit.
Pre-assignment Detail	Open label study

Arm/Group Title	Noncardiac Surgery
Arm/Group Description	VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Period Title: Overall Study
STARTED	323
COMPLETED	0
NOT COMPLETED	323

Baseline Characteristics

Arm/Group Title	Noncardiac Surgery
Arm/Group Description	VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Overall Participants	323
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (9.3)
Sex: Female, Male (Count of Participants)
Female	164 50.8%
Male	159 49.2%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Accuracy
Description	Accuracy of VectraplexECG System with CEB
Time Frame	1 minute to complete the test

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Noncardiac Surgery
Arm/Group Description	VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
Measure Participants	0

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Arm/Group Title	Noncardiac Surgery
Arm/Group Description	VectraplexECG System with CEB® used after surgery and on day 1, 2, and 3 postoperatively
All Cause Mortality
	Noncardiac Surgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Noncardiac Surgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Noncardiac Surgery
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.