Atrial FibrillationNCT00412438
Investigation of Genetic Risk of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Nagoya University at 1 site in Japan.
Trial summary
The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is responsible for substantial morbidity and mortality independent of associated heart disease or other risk factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2006to not given
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of atrial fibirillation
Who cannot join
- coronary artery disease
- severe valvular heart disease
- cardiomyopathy
- heart failure
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Bio-information Analysis, Research Institute of Enviromental Medicine, Nagoya University
Nagoya, Aichi-ken
Kenji Yasui, MD, PhD, +81-52-6211, kenji@riem.nagoya-u.ac.jp
Masaki Yamauchi, MD, +81-52-6211, g030744d@mbox.nagoya-u.ac.jp
About this study
The atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is responsible for substantial morbidity and mortality independent of associated heart disease or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains significantly associated with excess mortality rates. The current unsatisfactory treatment for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation. Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study. Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart failure were excluded from the study.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Kenji Yasui, MD, Phd, Study chair, Department of Bio-information Analysis, Research Institute of Enviromental Medicine, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412438
- Sponsor's protocol ID
- RIEM-G-1
- Status last verified
- Dec 2006
- First submitted
- 15 Dec 2006
- Last updated
- 18 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Genetic Risk of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00412438
- Acronym / sponsor ID
- RIEM-G-1
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 18 Dec 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 atrial fibrillation (AF) is the most common cardiac rhythm disturbance that is responsible for substantial morbidity and mortality independent of associated heart disease or other risk factors. Even in the absence of preexisting cardiovascular disease, AF remains significantly associated with excess mortality rates. The current unsatisfactory treatment for AF comes from lack of understanding of the pathophysiology of AF. The purpose of this study is to identify gene polymorphisms that confer susceptibility to atrial fibrillation. Patients with AF（N=500） and healthy volunteer（N=1000） without AF are enrolled in this study. Patients with coronary artery disease, severe valvular heart disease, cardiomyopathy or heart failure were excluded from the study.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of atrial fibirillation
Key exclusion criteria (4 listed)
- coronary artery disease
- severe valvular heart disease
- cardiomyopathy
- heart failure
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2006.
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Atrial Fibrillation (AF)
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.
Kenji Yasui, MD, Phd study chair
Department of Bio-information Analysis, Research Institute of Enviromental Medicine, Nagoya 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 Atrial Fibrillation, run by Nagoya University at 1 site in Japan.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Dec 2006. 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 Japan. 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?
Contact Kenji Yasui, MD, PhD (+81-52-788-6211, kenji@riem.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 18 Dec 2006.