Cardiac SurgeryNCT04543838
IMMPRES: Intraoperative Monitoring & Management to Reduce Stroke
A study testing Intervention in people with Cardiac Surgery, run by Parthasarathy Thirumala at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Intraoperative Monitoring and Management Protocol to Reduce Strokes (IMMPRES): Pilot Study
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.
Read the detailed description
If the patient is eligible, interested, and provides consent, they will complete initial preoperative baseline surveys and assessments. These assessments include: Medical History, Medications, Neurological Exam, NIH stroke Scale, Questionnaire for Verifying Stroke-Free Status (QVSFS), Delirium Screen, Modified Rankin Scale, Barthel Index, Cognitive Assessment: The Montreal Cognitive Assessment (MoCA), Depression Scale, and Quality of Life scale. General history, risk factor profile and physical examination (H\&P) will be performed prior to entering the study. Neurological examinations, NIHSS, Modified Rankin Scale and Barthel Index will be performed by study neurologist. A Questionnaire for Verifying Stroke-Free Status (revised Questionnaire for Verifying Stroke-Free Status (QVSFS)), QOL assessment, Delirium and Cognitive assessment will be administered to each potentially eligible patient by a research coordinator. Subjects of child bearing age will complete a pregnancy test.
Baseline surveys and assessments will collected during a pre-operative session, either in conjunction with a pre-op clinic visit in-person prior to surgery during their surgical admission. This will allow maximum flexibility in timing, without interfering with clinical care.
Clinically collected data will be abstracted from the electronic medical record (EMR) for research purposes. We will review the patients preoperative medical records to screen patients for the use of intraoperative monitoring. This is currently a standard clinical practice. After enrollment, the subject will be randomized into the control or intervention group. Subjects will be computer randomized to condition 1:1. It will take approximately a half an hour to complete surveys and study procedures. On the day of surgery, EEG and somatosensory evoked potentials assessments will be performed preoperatively.
Procedure: The cardiac surgeons who will be performing surgery will be informed by the principal investigator. The medical management of patients before, during, and after the procedure will be continued as routine medical care in standard medical therapy group. In the intervention group, standard medical therapy with intraoperative monitoring and management protocol will be done. Our IMMP will be a) intraoperative monitoring with SSEP and EEG during surgery and continued for 4 hours after; b) management protocol will be treating patients based on a SSEP and/or EEG changes. In patients with bilateral SSEP and/or EEG changes, we will aim for a MAP target of the greater of 20% above the patient's preoperative baseline or an absolute threshold of 80 mmHg. In patients with persistent unilateral SSEP and/or EEG changes, the higher MAP target will be maintained followed by immediate post-operative evaluation for stroke.
In the control group, the patient will receive standard of care.
Post-Procedure/Pre-Discharge: Brief history and physical examination daily while patient is in hospital. Neurological examination performed by study Neurologist. Delirium screen will be performed. NIH Stroke Scale (NIHSS) performed by study neurologist 18 to 54 hours post procedure. MRI will be performed before discharge. The MRI will be completed at the MRI Research Center.The Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 30 days post-op: Modified Rankin Scale, Barthel Index, Questionnaire for Verifying Stroke-Free Status (QVSFS), Quality of Life Assessment, and Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 1 year: Neurological exam, Modified Rankin Scale, Barthel Index, TIA/Stroke Questionnaire, Quality of Life Assessment and cognitive evaluation will be performed.
- Conditions
- Cardiac Surgery
- Being tested
- Intervention, Standard of Care BP management
- Keywords
- Cardiac Disease, Intraoperative Hypertension, Cardiac Surgery, Intraoperative Stroke, Perioperative Hypertension, Acute Perioperative Covert Stroke, Perioperative Complication
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDiagnostic test
Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring
Standard of Care BP managementOther
If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Diagnostic Test: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post-operative day 30
Secondary outcomes (9)
Proportion of Patients With Cognitive Decline
Proportion of patients with cognitive decline will be assessed by observing patients who score up to 2 points or more on the Montreal Cognitive Assessment
Measured: post-operative 1 year
Proportion of Patients With Transient Ischemic Attack
Proportion of patients with transient ischemic attack will be abstracted from subject EMR.
Measured: post-operative 1 year
Proportion of Patients With Delirium
Proportion of patients with delirium will be abstracted from subject EMR.
Measured: post-operative 1 year
Proportion of Patients With Clinical Stroke
Proportion of patients with clinical stroke will be abstracted from subject EMR.
Measured: post-operative 1 year
Proportion of Patients With Composite of Clinical Stroke
Proportion of patients with composite of clinical stroke will be abstracted from subject EMR.
Measured: post-operative 1 year
Proportion of Patients With MACE (Death From Any Cause, Non-fatal MI and Stroke)
Proportion of patients with MACE (death from any cause, non-fatal MI and stroke) will be abstracted from subject EMR.
Measured: post-operative 1 year
Proportion of Patients With a Decrease in EuroQol 5-dimension (EQ-5D)
Proportion of patients with a decrease in quality of life will be assessed by the EuroQol 5-dimension (EQ-5D). The EQ-5D questionnaire consists of two parts. The first part contains the EQ-5D descriptive system, comprising of 5 questions regarding mobility, selfcare, usual activities, pain, and depression (scores range from 0 to 1). The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state" (scores range from 0 to 100; higher values are better). scores.
Measured: post-operative 1 year
Proportion of Patients With a Discrete Diffusion-weighted Imaging (DWI) Lesion
Proportion of patients with a discrete DWI lesion will be abstracted from subject EMR.
Measured: post-operative 1 year
Overall Volume of DWI Lesion Burden
Overall volume of DWI lesion burden will be abstracted from subject EMR.
Measured: post-operative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start20 Apr 2021
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Why it stopped: Staffing, funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective single-blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parthasarathy Thirumala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Parthasarathy Thirumala, University of Pittsburgh
- Investigators
- Parthasarathy Thirumala, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543838
- Sponsor's protocol ID
- STUDY20070328
- Status last verified
- Nov 2024
- First submitted
- 2 Sep 2020
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Monitoring and Management Protocol to Reduce Strokes (IMMPRES): Pilot Study
- ClinicalTrials.gov ID
- NCT04543838
- Acronym / sponsor ID
- STUDY20070328
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac Disease, Intraoperative Hypertension, Cardiac Surgery, Intraoperative Stroke, Perioperative Hypertension, Acute Perioperative Covert Stroke, Perioperative Complication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing, funding
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Parthasarathy ThirumalaUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If the patient is eligible, interested, and provides consent, they will complete initial preoperative baseline surveys and assessments. These assessments include: Medical History, Medications, Neurological Exam, NIH stroke Scale, Questionnaire for Verifying Stroke-Free Status (QVSFS), Delirium Screen, Modified Rankin Scale, Barthel Index, Cognitive Assessment: The Montreal Cognitive Assessment (MoCA), Depression Scale, and Quality of Life scale. General history, risk factor profile and physical examination (H\&P) will be performed prior to entering the study. Neurological examinations, NIHSS, Modified Rankin Scale and Barthel Index will be performed by study neurologist. A Questionnaire for Verifying Stroke-Free Status (revised Questionnaire for Verifying Stroke-Free Status (QVSFS)), QOL assessment, Delirium and Cognitive assessment will be administered to each potentially eligible patient by a research coordinator. Subjects of child bearing age will complete a pregnancy test.
Baseline surveys and assessments will collected during a pre-operative session, either in conjunction with a pre-op clinic visit in-person prior to surgery during their surgical admission. This will allow maximum flexibility in timing, without interfering with clinical care.
Clinically collected data will be abstracted from the electronic medical record (EMR) for research purposes. We will review the patients preoperative medical records to screen patients for the use of intraoperative monitoring. This is currently a standard clinical practice. After enrollment, the subject will be randomized into the control or intervention group. Subjects will be computer randomized to condition 1:1. It will take approximately a half an hour to complete surveys and study procedures. On the day of surgery, EEG and somatosensory evoked potentials assessments will be performed preoperatively.
Procedure: The cardiac surgeons who will be performing surgery will be informed by the principal investigator. The medical management of patients before, during, and after the procedure will be continued as routine medical care in standard medical therapy group. In the intervention group, standard medical therapy with intraoperative monitoring and management protocol will be done. Our IMMP will be a) intraoperative monitoring with SSEP and EEG during surgery and continued for 4 hours after; b) management protocol will be treating patients based on a SSEP and/or EEG changes. In patients with bilateral SSEP and/or EEG changes, we will aim for a MAP target of the greater of 20% above the patient's preoperative baseline or an absolute threshold of 80 mmHg. In patients with persistent unilateral SSEP and/or EEG changes, the higher MAP target will be maintained followed by immediate post-operative evaluation for stroke.
In the control group, the patient will receive standard of care.
Post-Procedure/Pre-Discharge: Brief history and physical examination daily while patient is in hospital. Neurological examination performed by study Neurologist. Delirium screen will be performed. NIH Stroke Scale (NIHSS) performed by study neurologist 18 to 54 hours post procedure. MRI will be performed before discharge. The MRI will be completed at the MRI Research Center.The Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 30 days post-op: Modified Rankin Scale, Barthel Index, Questionnaire for Verifying Stroke-Free Status (QVSFS), Quality of Life Assessment, and Cognitive Assessment: The Montreal Cognitive Assessment (MoCA) will be performed.
Follow-up: At 1 year: Neurological exam, Modified Rankin Scale, Barthel Index, TIA/Stroke Questionnaire, Quality of Life Assessment and cognitive evaluation will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized prospective single-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care BP managementControl 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). |
| EEG & SSEP monitoring | Experimental | Diagnostic Test: InterventionIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionElectroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring | Diagnostic test | EEG & SSEP monitoring |
| Standard of Care BP managementIf blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented | Other | Standard of Care |
Primary outcome
Proportion of Patients With a New Clinical Stroke, New Overt Stroke, and Death
Time frame: post-operative day 30
Proportion of patients with a new clinical stroke, new overt stroke, and death will be abstracted from subject EMR.
9 secondary outcomes
Proportion of Patients With Cognitive Decline
Time frame: post-operative 1 year
Proportion of Patients With Transient Ischemic Attack
Time frame: post-operative 1 year
Proportion of Patients With Delirium
Time frame: post-operative 1 year
Proportion of Patients With Clinical Stroke
Time frame: post-operative 1 year
Proportion of Patients With Composite of Clinical Stroke
Time frame: post-operative 1 year
Proportion of Patients With MACE (Death From Any Cause, Non-fatal MI and Stroke)
Time frame: post-operative 1 year
Proportion of Patients With a Decrease in EuroQol 5-dimension (EQ-5D)
Time frame: post-operative 1 year
Proportion of Patients With a Discrete Diffusion-weighted Imaging (DWI) Lesion
Time frame: post-operative 1 year
Overall Volume of DWI Lesion Burden
Time frame: post-operative 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parthasarathy Thirumala, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cardiac Surgery, run by Parthasarathy Thirumala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With a New Clinical Stroke, New Overt Stroke, and Death (time frame: post-operative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.