Predicting the Development of Myocardial Depression in Acute Neurological Patients

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

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.
    

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


Primary Outcome

Association of plasma catecholamine levels with stress induced cardiomyopathy

Secondary Outcome

 Association of ST-T changes on EKG with stress induced cardiomyopathy

Condition

Myocardial Depression



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

10

Start Date

December 3, 2018

Completion Date

June 30, 2022

Primary Completion Date

December 31, 2021

Eligibility 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
      

Gender

Female

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shraddha Mainali, 614.293.4969, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03801694

Organization ID

2018H0436


Responsible Party

Principal Investigator

Study Sponsor

Ohio State University


Study Sponsor

Shraddha Mainali, Principal Investigator, Ohio State University


Verification Date

December 2020