Intraoperative Stroke Prevention Strategy for Stroke Risk During Cardiac Surgery

Recruiting in Palo Alto (17 mi)

Overseen byParthasarathy Thirumala, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Parthasarathy Thirumala

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The objective of this study is to prospectively evaluate the therapeutic effectiveness of with blood pressure management using intraoperative neurophysiological monitoring with SSEP and EEG to reduce perioperative stroke. The central hypothesis is that perioperative stroke occurs from emboli in the setting of significant hypoperfusion resulting in ischemia, which leads to infarction. The impact of the proposed research is that, if significant SSEP and EEG changes can be used to identify cerebral perfusion, then timely therapeutic interventions to effectively reduce the impact of perioperative stroke can be directed.

Research Team

Parthasarathy Thirumala, MD, MS

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

Patients who are 18 years of age or older at screening

Patients with the ability to provide written informed consent

You have a scheduled heart surgery at UPMC.

Exclusion Criteria

Patients who, as determined by the investigators, are unable to complete the preoperative testing

You have metal inside your body that cannot be used with an MRI machine.

Patient who, as determined by the investigators, are noncompliant or unable to complete follow-up assessments

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Treatment Details

Interventions

Intervention (Diagnostic Test)
Standard of Care BP management (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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).