Columbus, Ohio 43210

  • Acute Ischemic Stroke

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

2018H0436


NCT ID:

NCT03801694


Secondary ID:


Study Acronym:


Brief Title:

Predicting the Development of Myocardial Depression in Acute Neurological Patients


Official Title:

To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Tamara Strohm
Principal Investigator
Ohio State University
Primary Contact:Tamara Strohm, MD
6146888933
tamara.strohm@osumc.edu
Backup Contact:Erica Bell, PhD
614.293.3019
erica.bell@osumc.edu

Study Dates

Start Date:December 3, 2018
Completion Date:June 30, 2023
Completion Type:Anticipated
Primary Completion Date:December 31, 2022
Primary Completion Type:Anticipated
Verification Date:May 2022
Last Changed Date:May 24, 2022
First Received Date:January 3, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Association of plasma catecholamine levels with stress induced cardiomyopathy
Time Frame:up to 5 days
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Association of troponin levels with stress induced cardiomyopathy
Time Frame:up to 5 days
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Association of ST-T changes on EKG with stress induced cardiomyopathy
Time Frame:up to 5 days
Safety Issues:False
Description: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.

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Baseline plasma catecholamine levels, transthoracic ECHO(TTE), Troponin T, EKG and BNP will be obtained. Thereafter, we will follow daily plasma catecholamine levels, troponin, EKG and BNP up to 5 days from the study onset
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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