Myocardial DepressionNCT03801694
Predicting the Development of Myocardial Depression in Acute Neurological Patients
An observational study of Myocardial Depression and Takotsubo Syndrome, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Myocardial Depression, Takotsubo Syndrome, Subarachnoid Hemorrhage
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 14 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients
The purpose of this study is to assess the levels of serum catecholamines associated with myocardial depression (MD) in patients with acute neurological injury.
Read the 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.
- Medical subject headings
- Takotsubo Cardiomyopathy, Subarachnoid Hemorrhage, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 5 days
Secondary outcomes (1)
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.
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start3 Dec 2018
- Primary completion14 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DepressionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara Strohm, Ohio State University
- Investigators
- Tamara Strohm, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801694
- Sponsor's protocol ID
- 2018H0436
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2019
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Role of Plasma Catecholamine Levels in Predicting the Development of Myocardial Depression in Acute Neurological Patients
- ClinicalTrials.gov ID
- NCT03801694
- Acronym / sponsor ID
- 2018H0436
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of plasma catecholamine levels with stress induced cardiomyopathy
Time frame: up to 5 days
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.
Association of troponin levels with stress induced cardiomyopathy
Time frame: up to 5 days
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.
1 secondary outcome
Association of ST-T changes on EKG with stress induced cardiomyopathy
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Strohm principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Depression and Takotsubo Syndrome, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of plasma catecholamine levels with stress induced cardiomyopathy (time frame: up to 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.