- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02062957
Endovascular Function in Atrial Fibrillation (AF) Patients (HEAF)
February 23, 2014 updated by: Guangzhen Zhong, Beijing Chao Yang Hospital
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100020
- Recruiting
- Beijing ChaoYang Hospital
-
Contact:
- Lin Han, Bachelor
- Phone Number: 86-10185231512
-
Principal Investigator:
- Guangzhen Zhong, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with AF
Description
Inclusion Criteria:
- ≥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).
Exclusion Criteria:
- patients with cerebralvascular disease
- patients with coronary disease
- patients with peripheric artery disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
predictive effect of endovascular function on recurrence of AF
Time Frame: Up to 1 year
|
We will do the multi-logistic analysis of the recurrence of AF.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 12, 2014
First Posted (ESTIMATE)
February 14, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 25, 2014
Last Update Submitted That Met QC Criteria
February 23, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NF81300148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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