PAT ResultHEAFNCT02062957
Endovascular Function in Atrial Fibrillation (AF) Patients
An observational study of PAT Result, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
1. recruit 50 patients with atrial fibrillation and 30 controls 2. endovascular function assessment with Peripheral Arterial Tonometry (PAT) 3. follow up the occurence of AF Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PAT Result
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jul 2014
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with AF
Who may be able to join
- ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
- electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
- electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
Who cannot join
- patients with cerebralvascular disease
- patients with coronary disease
- patients with peripheric artery disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, 100020
Lin Han, Bachelor, 86-10185231512
Guangzhen Zhong, Doctor
About this study
Official title: Endovascular Function in Patients With Atrial Fibrillation
- recruit 50 patients with atrial fibrillation and 30 controls
- endovascular function assessment with Peripheral Arterial Tonometry (PAT)
- follow up the occurence of AF
- Conditions
- PAT Result
What is being measured
The primary outcome is the main question the study is designed to answer.
endovascular function results
The method to assess the endovascular function is PAT. The index is Reactive hyperemia index (RHI). RHI between patients and control will be compared.
Measured: Up to 24 weeks.
Secondary outcomes (1)
predictive effect of endovascular function on recurrence of AF
We will do the multi-logistic analysis of the recurrence of AF.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAT ResultStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangzhen Zhong, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062957
- Sponsor's protocol ID
- NF81300148
- Acronym
- HEAF
- Status last verified
- Feb 2014
- First submitted
- 11 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Function in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02062957
- Acronym / sponsor ID
- HEAF / NF81300148
- Conditions
- PAT Result
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (estimated)
- First posted
- 14 Feb 2014 (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.
- recruit 50 patients with atrial fibrillation and 30 controls
- endovascular function assessment with Peripheral Arterial Tonometry (PAT)
- follow up the occurence of AF
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with AF
Key inclusion criteria (3 listed)
- ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
- electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
- electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
Key exclusion criteria (3 listed)
- patients with cerebralvascular disease
- patients with coronary disease
- patients with peripheric artery disease
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
endovascular function results
Time frame: Up to 24 weeks.
The method to assess the endovascular function is PAT. The index is Reactive hyperemia index (RHI). RHI between patients and control will be compared.
1 secondary outcome
predictive effect of endovascular function on recurrence of AF
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
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 PAT Result, run by Beijing Chao Yang Hospital at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 25 Feb 2014. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endovascular function results (time frame: Up to 24 weeks.). 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 25 Feb 2014.