CardiomyopathyNCT00322582
The Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic Cardiomyopathy
An observational study of Cardiomyopathy, run by Carmel Medical Center at 1 site in Israel.
Trial summary
In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Feb 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: History of cardiomyopathy
Who may be able to join
- history of cardiomyopathy
- etiology not known
- family history of cardiomyopathy
- ability to understand and sign the informed consent
Who cannot join
- refusal to participate
- pregnancy
- current participation in another active treatment study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Labeled of the Study the Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic
In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.
Read the detailed description
A total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.
- Conditions
- Cardiomyopathy
- Keywords
- familial cardiomyopathy, genetics analysis
- Medical subject headings
- Cardiomyopathies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: no financial resources were available to complete the study
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 CardiomyopathyStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Offer Amir, Carmel Medical Center
- Investigators
- Offer Amir, MD, Study director, Lady Davis Carmel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322582
- Sponsor's protocol ID
- GEN/ICM
- Other IDs
- 136-2005
- Status last verified
- Jan 2007
- First submitted
- 5 May 2006
- Last updated
- 25 Jan 2012
- Results posted
- No
Publications
Murphy RT, Starling RC. Genetics and cardiomyopathy: where are we now? Cleve Clin J Med. 2005 Jun;72(6):465-6, 469-70, 472-3 passim. doi: 10.3949/ccjm.72.6.465.
PubMed 16018289
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Labeled of the Study the Genetic Basis for Familial Cardiomyopathy in Patients With Idiopathic
- ClinicalTrials.gov ID
- NCT00322582
- Acronym / sponsor ID
- GEN/ICM
- Conditions
- Cardiomyopathy
- Keywords
- familial cardiomyopathy, genetics analysis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: no financial resources were available to complete the study
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 May 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.
In many of the patients with cardiomyopathy, the etiology is not clear . In about 30% there is a family history of cardiomyopathy .Our aim is to study the genetics basis for these patients with cardiomyopathy with no clear etiology and who have a first degree family relative with cardiomyopathy as well.
Detailed description
A total of 950 blood samples will be collected from patients with idiopathic cardiomyopathy and their relatives and will be analysed for genetics analysis.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- History of cardiomyopathy
Key inclusion criteria (4 listed)
- history of cardiomyopathy
- etiology not known
- family history of cardiomyopathy
- ability to understand and sign the informed consent
Key exclusion criteria (3 listed)
- refusal to participate
- pregnancy
- current participation in another active treatment study
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: no financial resources were available to complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Background: PubMed 16018289Murphy RT, Starling RC. Genetics and cardiomyopathy: where are we now? Cleve Clin J Med. 2005 Jun;72(6):465-6, 469-70, 472-3 passim. doi: 10.3949/ccjm.72.6.465.
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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.
Offer Amir, MD study director
Lady Davis Carmel Hospital
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 Cardiomyopathy, run by Carmel Medical Center at 1 site in Israel.
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 4 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: stopped early, as of the sponsor's last update on 25 Jan 2012. 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 Israel. 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 was stopped early (reason given: no financial resources were available to complete the 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322582, 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 25 Jan 2012.