Predicting the Development of Myocardial Depression in Acute Neurological Patients

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801694
• Other study ID #: 2018H0436
• Status: Completed
• Start date: December 3, 2018
• Est. completion date: April 14, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 14, 2024
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Depression
• Depressive Disorder
• Hemorrhage
• Ischemic Stroke
• Myocardial Depression
• Subarachnoid Hemorrhage
• Takotsubo Cardiomyopathy
• Takotsubo Syndrome

Locations

Country	Name	City	State
United States	The Ohio Sate University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of plasma catecholamine levels with stress induced cardiomyopathy	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
Primary	Association of troponin levels with stress induced cardiomyopathy	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	Association of ST-T changes on EKG with stress induced cardiomyopathy	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