Clinical trial NCT03801694: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Depression
Takotsubo Syndrome
Subarachnoid Hemorrhage
Acute Ischemic Stroke
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Association of plasma catecholamine levels with stress induced cardiomyopathy
timeFrame: up to 5 days
measure: Association of troponin levels with stress induced cardiomyopathy
timeFrame: up to 5 days
Secondary outcomes:
measure: Association of ST-T changes on EKG with stress induced cardiomyopathy
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio Sate University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tamara Strohm
role: PRINCIPAL_INVESTIGATOR
References: