ArrhythmiaDISCERNNCT00500708
Diagnostic Investigation of Sudden Cardiac Event Risk
An observational study of Arrhythmia and Cardiovascular Diseases, run by CardioDx at 8 sites in United States.
Trial summary
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arrhythmia, Cardiovascular Diseases, Heart Failure
- How many people
- 1,564 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2007to 1 Aug 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during follow-up in electrophysiology clinic as long as full device records are available since time of implant.
Who may be able to join
- Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for primary prevention
- Left ventricular ejection fraction (LVEF) ≤ 50 %
- Ability to collect clinical follow-up and endpoint information, including device interrogation data
Who cannot join
- Congenital heart disease
- Known inherited arrhythmia disorder
- Organ transplantation
- Inability to give informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alaska Heart Institute
Anchorage, Alaska, 99508
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27705
Minneapolis Heart Institute and Foundation
Minneapolis, Minnesota, 55407
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Palo Alto Medical Foundation
Palo Alto, California, 94301
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, 15212
Intermountain Healthcare
Salt Lake City, Utah, 84111
About this study
Official title: Identifying Markers That Predict Ventricular Arrhythmia Risk
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).
Read the detailed description
This is a prospective, multi-center, observational study. The research will be performed in three phases, each using distinct patient cohorts:
Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation
The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Failure, CVD
- Keywords
- Heart failure, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Coronary Heart Disease, Gene Expression, GES, CVD, CHD, Precision Medicine, Genome-wide association study, Cardiovascular Disease, CAD, GWAS, DISCERN
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Failure, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene discovery
Genome Wide Association Study (GWAS)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completion1 Aug 2011
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies 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
- 1,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, Study director, CardioDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500708
- Sponsor's protocol ID
- CDX_000003
- Other IDs
- DISCERN
- Acronym
- DISCERN
- Status last verified
- Oct 2017
- First submitted
- 11 Jul 2007
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hranitzky PM, Sehnert AJ, Blanchard JL, et al. Abstract 16410: Identification of novel genetic markers associated with lethal ventricular arrhythmias in heart failure patients: genome wide association study in the DISCERN cohort. Circulation. 2010;122. Abstract 16410.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Markers That Predict Ventricular Arrhythmia Risk
- ClinicalTrials.gov ID
- NCT00500708
- Acronym / sponsor ID
- DISCERN / CDX_000003
- Conditions
- Arrhythmia, Cardiovascular Diseases, Heart Failure, CVD
- Keywords
- Heart failure, Implanted Cardioverter Defibrillator, Biological Markers, Molecular Genetics, Coronary Heart Disease, Gene Expression, GES, CVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,564 participants (actual)
- Lead sponsor
- CardioDxIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 13 Jul 2007 (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 overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).
Detailed description
This is a prospective, multi-center, observational study. The research will be performed in three phases, each using distinct patient cohorts:
Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation
The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during follow-up in electrophysiology clinic as long as full device records are available since time of implant.
Key inclusion criteria (3 listed)
- Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for primary prevention
- Left ventricular ejection fraction (LVEF) ≤ 50 %
- Ability to collect clinical follow-up and endpoint information, including device interrogation data
Key exclusion criteria (4 listed)
- Congenital heart disease
- Known inherited arrhythmia disorder
- Organ transplantation
- 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.
Primary outcome
Gene discovery
Time frame: up to 3 years
Genome Wide Association Study (GWAS)
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 19 Oct 2017.
- Results publicationHranitzky PM, Sehnert AJ, Blanchard JL, et al. Abstract 16410: Identification of novel genetic markers associated with lethal ventricular arrhythmias in heart failure patients: genome wide association study in the DISCERN cohort. Circulation. 2010;122. Abstract 16410.
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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.
Michael Zapien, MS study director
CardioDx, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Cardiovascular Diseases, run by CardioDx at 8 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 3 inclusion and 4 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Gene discovery (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500708, which also lists 1 linked publication.
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 19 Oct 2017.