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Predicting the Development of Myocardial Depression in Acute Neurological Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03801694
Enrollment
4
Registered
2019-01-11
Start date
2018-12-03
Completion date
2024-04-14
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Myocardial Depression, Subarachnoid Hemorrhage, Takotsubo Syndrome

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.

Interventions

None listed

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association of plasma catecholamine levels with stress induced cardiomyopathyup to 5 daysBaseline 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.
Association of troponin levels with stress induced cardiomyopathyup to 5 daysBaseline 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

MeasureTime frameDescription
Association of ST-T changes on EKG with stress induced cardiomyopathyup to 5 daysBaseline 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026