- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801694
Predicting the Development of Myocardial Depression in Acute Neurological Patients
May 24, 2022 updated by: Tamara Strohm, Ohio State University
To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients
The purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (MD) in patients with acute neurological injury.
Study Overview
Status
Recruiting
Detailed Description
The purpose of this study is to investigate the level of plasma catecholamines, associated with myocardial depression (MD) as noted on Transthoracic ECHO (TTE) by evidence of wall motion abnormalities (WMA) with or without drop in ejection fraction or symptomatic heart failure (HF).
Takotsubo syndrome (TTS) is commonly diagnosed after the onset of HF once patients become symptomatic.
The investigators intend to study whether early MD can be detected by identifying certain levels of plasma catecholamines and whether the level correlates with severity of myocardial depression.
Identification of early MD changes can lead to alteration of management strategies and may help prevent worsening of HF.
Highly selected patients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring induced hypertension with the use of norepinephrine infusion will be recruited to enroll in this pilot study.
This group of patients are expected to have high circulating catecholamines and are more likely to develop MD.
Given the prevalence of TTS in females and elderly, 10 female patients >50 years admitted to the neuro ICU with diagnosis of either AIS or SAH will be enrolled.
Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c >8 and uncontrolled hypertension will be excluded.
Patients with poor ECHO windows will also be excluded.
Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will be obtained and will be followed daily through the study duration.
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tamara Strohm, MD
- Phone Number: 6146888933
- Email: tamara.strohm@osumc.edu
Study Contact Backup
- Name: Erica Bell, PhD
- Phone Number: 614.293.3019
- Email: erica.bell@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio Sate University
-
Contact:
- Shradda Mainali, MD
- Phone Number: 614-293-9274
- Email: shradda.mainali@osumc.edu
-
Contact:
- Carson Reider, PhD
- Phone Number: 614.293.9274
- Email: Carson.Reider@osumc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Highly selected partients with Subarachnoid Hemorrhage (SAH) or Acute Ischemic Stroke (AIS) requiring induced hypertension with the use of norepinephrine infusion will be involve in this pilot study.
Description
Inclusion Criteria:
- female patients >50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
- Only patients predicted to be on norepinephrine infusion for at least 48 hrs will be selected.
Exclusion Criteria:
- patients with known history of heart failure will be excluded
- Patients with history of coronary artery disease, smoking, poorly controlled diabetes with HbA1c >8 and uncontrolled hypertension will be excluded.
- Patients with poor ECHO windows will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association of plasma catecholamine levels with stress induced cardiomyopathy
Time Frame: up to 5 days
|
Baseline plasma catecholamine levels as well as daily levels will be measured until up to 5 days from study onset.
Baseline transthoracic ECHO followed by daily ECHO with strain imaging will be obtained to assess for evidence of myocardial depression.
The investigators will assess the correlation of plasma catecholamine levels (i.e level of dopamine, epinephrine and norepinephrine) in the development of myocardial depression.
In other words, the investigators will evaluate the level of catecholamines that is associated with stress induced cardiomyopathy.
If participants develop symptomatic heart failure before 5 days, study will stop at that point.
|
up to 5 days
|
Association of troponin levels with stress induced cardiomyopathy
Time Frame: up to 5 days
|
Baseline troponin level will be measured as well as daily levels will be obtained for 5 days.
The investigators will study the correlation of troponin levels with the myocardial depression noted on ECHO.
|
up to 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association of ST-T changes on EKG with stress induced cardiomyopathy
Time Frame: up to 5 days
|
Baseline EKG and daily EKG measurements will be taken.
These will be examined for ST-T wave changes in participants with evidence of myocardial depression on ECHO.
|
up to 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tamara Strohm, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 3, 2018
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
June 30, 2023
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 10, 2019
First Posted (ACTUAL)
January 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Stroke
- Intracranial Hemorrhages
- Ventricular Dysfunction, Left
- Ventricular Dysfunction
- Depression
- Depressive Disorder
- Ischemic Stroke
- Hemorrhage
- Subarachnoid Hemorrhage
- Takotsubo Cardiomyopathy
Other Study ID Numbers
- 2018H0436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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