IMMPRES: Intraoperative Monitoring & Management to Reduce Stroke

NCT04543838 | Terminated Results FDA Device

• 1 other identifier: STUDY20070328
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

Cardiac Disease; Intraoperative Hypertension; Cardiac Surgery; Intraoperative Stroke; Perioperative Hypertension; Acute Perioperative Covert Stroke; Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With a New Clinical Stroke, New Overt Stroke, and Death

  Proportion of patients with a new clinical stroke, new overt stroke, and death will be abstracted from subject EMR.

  post-operative day 30

Secondary Outcomes (9)

• Proportion of Patients With Cognitive Decline

  post-operative 1 year

• Proportion of Patients With Transient Ischemic Attack

  post-operative 1 year

• Proportion of Patients With Delirium

  post-operative 1 year

• Proportion of Patients With Clinical Stroke

  post-operative 1 year

• Proportion of Patients With Composite of Clinical Stroke

  post-operative 1 year

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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).

Other: Standard of Care BP management

EEG & SSEP monitoring

EXPERIMENTAL

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.

Diagnostic Test: Intervention

Interventions

Intervention DIAGNOSTIC_TEST

Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring

EEG & SSEP monitoring

Standard of Care BP management OTHER

If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for Cardiac surgery at UPMC
• Patients who are 18 years of age or older at screening
• Patients with the ability to provide written informed consent

You may not qualify if:

• Patient who, as determined by the investigators, are noncompliant or unable to complete follow-up assessments
• Patient with history of dementia or other cognitive impairment. History of dementia will be determined by medical record review.
• Patients who, as determined by the investigators, are unable to complete the preoperative testing
• Have an implanted medical electronic device
• Have indwelling or implanted metal in their body that is not MRI-compatible
• Have claustrophobia. This will be measured by utilizing the standard screening questionnaire for MRI.
• Develop back pain when lying flat for more than 1 hour
• Pregnancy

Sponsors & Collaborators

• Parthasarathy Thirumala: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Parthasarathy Thirumala, MD
• Organization: UPMC

thirumalapd@upmc.edu

412-648-4208

Study Officials

• Parthasarathy Thirumala, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized prospective single-blind clinical trial

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 10, 2020
• Study Start: April 20, 2021
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)