Predicting the Development of Myocardial Depression in Acute Neurological Patients

NCT03801694 | Completed

• 1 other identifier: 2018H0436
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  up to 5 days

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: female patients \>50 years admitted to the neuro ICU with diagnosis of either acute ischemic stroke or subarachnoid hemorrhage
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio Sate University

Columbus, Ohio, 43210, United States

Location

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

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Subarachnoid Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Tamara Strohm

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- Neurology

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 11, 2019
• Study Start: December 3, 2018
• Primary Completion: April 14, 2024
• Study Completion: April 14, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)