ArrhythmiasNCT00284453
Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm
An observational study of Arrhythmias, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Peripheral blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2008to Dec 2018
- 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: Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study
Who may be able to join
- ICD patients at least 18 years of age that present within a 72 hour period: 1) > 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
- Able to give informed consent
Who cannot join
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15216
About this study
Official title: Gene Expression in ICD Patients With Electrical Storm
The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.
Read the detailed description
This is a study of patients with ICD implants who present with multiple(>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).
- Conditions
- Arrhythmias
- Being tested
- Peripheral blood sampling
- Keywords
- ventricular, arrhythmias, ICD, VT storm, ICD patients with VT storm
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samplingProcedure or surgery
blood samples will be collected within 72 hours of subjects receiving >2, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Forty(40)subjects that have received >2 appropriate ICD shock therapies Receives: Procedure: Peripheral blood sampling | |
| 2 | Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies Receives: Procedure: Peripheral blood sampling | |
| 3 | Ten(10)subjects that received inappropriate therapies from their ICD Receives: Procedure: Peripheral blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Testing
Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days)
Measured: Day 1 Enrollment
Genetic Testing
Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days)
Measured: Day 90 +/- 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study start26 Aug 2008
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Jain, University of Pittsburgh
- Investigators
- Sandeep K. Jain, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284453
- Sponsor's protocol ID
- 0510087
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2006
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression in ICD Patients With Electrical Storm
- ClinicalTrials.gov ID
- NCT00284453
- Acronym / sponsor ID
- 0510087
- Conditions
- Arrhythmias
- Keywords
- ventricular, arrhythmias, ICD, VT storm, ICD patients with VT storm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 26 Aug 2008 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Jan 2006 (estimated)
- 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 the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.
Detailed description
This is a study of patients with ICD implants who present with multiple(>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Peripheral blood samplingForty(40)subjects that have received >2 appropriate ICD shock therapies |
| 2 | – | Procedure: Peripheral blood samplingTwenty(20)subjects that have received 1-2(low level)appropriate ICD therapies |
| 3 | – | Procedure: Peripheral blood samplingTen(10)subjects that received inappropriate therapies from their ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study
Key inclusion criteria (2 listed)
- ICD patients at least 18 years of age that present within a 72 hour period: 1) > 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
- Able to give informed consent
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplingblood samples will be collected within 72 hours of subjects receiving >2, 1-2(low level) or inappropriate therapies, device data and repeat bloodwork in 3 months(+/- 4weeks). | Procedure or surgery | 1, 2, 3 |
Primary outcome
Genetic Testing
Time frame: Day 1 Enrollment
Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days)
Genetic Testing
Time frame: Day 90 +/- 30 days
Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 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 12 Feb 2019.
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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.
Sandeep K. Jain, M.D. principal investigator
University of Pittsburgh
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 Arrhythmias, run by University of Pittsburgh 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 2 inclusion and 1 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 12 Feb 2019. 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?
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?
Genetic Testing (time frame: Day 1 Enrollment). 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 12 Feb 2019.