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Predicting the Development of Myocardial Depression in Acute Neurological Patients

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ClinicalTrials.gov Identifier: NCT03801694
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Shraddha Mainali, Ohio State University

Brief Summary:
The purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (MD) in patients with acute neurological injury.

Condition or disease
Myocardial Depression Takotsubo Syndrome Subarachnoid Hemorrhage Acute Ischemic Stroke

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
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
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


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients >50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801694


Contacts
Contact: Shraddha Mainali, MD 614.293.4969 shradda.mainali@osumc.edu
Contact: Carson Reider, PhD 614.293.9274 Carson.Reider@osumc.edu

Locations
United States, Ohio
The Ohio Sate University Recruiting
Columbus, Ohio, United States, 43210
Contact: Shradda Mainali, MD    614-293-9274    shradda.mainali@osumc.edu   
Contact: Carson Reider, PhD    614.293.9274    Carson.Reider@osumc.edu   
Sponsors and Collaborators
Ohio State University

Responsible Party: Shraddha Mainali, Assistant Professor- Neurology, Ohio State University
ClinicalTrials.gov Identifier: NCT03801694     History of Changes
Other Study ID Numbers: 2018H0436
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hemorrhage
Subarachnoid Hemorrhage
Takotsubo Cardiomyopathy
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases