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Diagnostic Test

Intraoperative Stroke Prevention Strategy for Stroke Risk During Cardiac Surgery

N/A

Waitlist Available

Led By Keith Vogt, MD, PhD

Research Sponsored by Parthasarathy Thirumala

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for Cardiac surgery at UPMC

Patients who are 18 years of age or older at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative 1 year

Awards & highlights

Study Summary

This trial is testing whether cerebral perfusion changes can help predict and reduce the risk of perioperative stroke.

Who is the study for?

This trial is for adults over 18 who can consent and are scheduled for cardiac surgery at UPMC. It's not suitable for those with metal implants non-compatible with MRI, electronic devices implanted, cognitive impairments like dementia, pregnant individuals, or those unable to lie flat due to back pain.Check my eligibility

What is being tested?

The IMMPRES study tests if monitoring brain activity (SSEP and EEG) during heart surgery and managing blood pressure can reduce strokes. The idea is that detecting changes in brain signals could help adjust treatment quickly to prevent stroke damage.See study design

What are the potential side effects?

While the trial itself may not introduce new side effects beyond standard risks of cardiac surgery, potential discomforts include lying still for long periods during neurophysiological monitoring and undergoing additional interventions based on monitoring results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have a scheduled heart surgery at UPMC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with a new clinical stroke, new overt stroke, and death

Secondary outcome measures

Overall volume of DWI lesion burden

Proportion of patients with MACE (death from any cause, non-fatal MI and stroke)

Proportion of patients with a decrease in quality of life

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EEG & SSEP monitoringExperimental Treatment1 Intervention

Intervention will include standard of care pain management during the postoperative period. Participants in this arm will receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP). EEG will be used to manage blood pressure.

Group II: Standard of CareActive Control1 Intervention

Control will include standard of care pain management during the postoperative period. Participants in this arm will not receive an Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention

2011

Completed Phase 4

~73780

0 / 2Eligibility criteria met