CardiomyopathiesTASC01NCT03252613
Translational Approaches to Septic Cardiomyopathy
An observational study of Cardiomyopathies and Sepsis, run by Samuel Brown at 2 sites in United States.
Trial summary
This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Sepsis, Septic Shock
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 May 2017to 27 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of study subjects must be 18 years of age, admitted to an ICU and have sepsis or septic shock as defined in the above inclusion criteria.
Who may be able to join
- At least 18 years of age Admitted to the ICU
- SEPSIS PATIENTS:
- Sepsis patients must have:
- Suspected or confirmed infection AND
- Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
- OR
Show all 16Show fewer
- SEPTIC SHOCK PATIENTS:
- AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:
- Suspected or confirmed infection AND
- Lactate > 2 mmol/L AND
- Receiving vasopressors
- EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known preexisting heart disease Known severe valvular disease (regurgitation or stenosis)
- Major cardiac dysrhythmia such as:
- Ventricular tachycardia (V-tach)
- Ventricular Fibrillation (V-fib)
- Third degree heart block (complete hear block or complete AV block)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermoutain Medical Center
Murray, Utah, 84157
Stanford University
Stanford, California, 94305
About this study
This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.
- Conditions
- Cardiomyopathies, Sepsis, Septic Shock
- Keywords
- septic cardiomyopathy, cytokine, iPSC, Inducible pluripotent stem cell
- Medical subject headings
- Cardiomyopathies, Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of cytokine profile with left ventricular global longitudinal strain
This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.
Measured: Day 1
Secondary outcomes (1)
Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes
This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start19 May 2017
- Primary completion27 Oct 2019 (estimated)
- Study completion27 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Brown
- Sponsor type
- University, hospital or other
- Collaborators
- Euan Ashley
- Responsible party
- Sponsor-investigator, Samuel Brown, Intermountain Health Care, Inc.
- Investigators
- Samuel Brown, MD, Principal investigator, Intermountain Health Care, Inc.Euan Ashley, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252613
- Sponsor's protocol ID
- 1050374
- Acronym
- TASC01
- Status last verified
- Dec 2018
- First submitted
- 15 Aug 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be a database/tissue bank for future research
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Approaches to Septic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03252613
- Acronym / sponsor ID
- TASC01 / 1050374
- Conditions
- Cardiomyopathies, Sepsis, Septic Shock
- Keywords
- septic cardiomyopathy, cytokine, iPSC, Inducible pluripotent stem cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Samuel BrownUniversity, hospital or other
- Collaborators
- Euan Ashley
- Study start
- 19 May 2017 (actual)
- Primary completion
- 27 Oct 2019 (estimated)
- Study completion
- 27 Oct 2019 (estimated)
- First posted
- 17 Aug 2017 (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.
This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of study subjects must be 18 years of age, admitted to an ICU and have sepsis or septic shock as defined in the above inclusion criteria.
Key inclusion criteria (16 listed)
- At least 18 years of age Admitted to the ICU
- Suspected or confirmed infection AND
- Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
- OR
- Suspected or confirmed infection AND
Key exclusion criteria (0 listed)
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
Correlation of cytokine profile with left ventricular global longitudinal strain
Time frame: Day 1
This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.
1 secondary outcome
Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes. There will be a database/tissue bank for future research
Related trials for Cardiomyopathies
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
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.
Samuel Brown, MD principal investigator
Intermountain Health Care, Inc.
Euan Ashley, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Sepsis, run by Samuel Brown at 2 sites 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 16 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Correlation of cytokine profile with left ventricular global longitudinal strain (time frame: Day 1). 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 24 Dec 2018.