Atrial FibrillationNCT02485288
PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
An observational study of Atrial Fibrillation, run by University of Pittsburgh at 4 sites in United States.
Trial summary
The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,500 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2015to Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential participants for the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort will include patients identified through EHRs at the participating PaTH sites, using the eligibility criteria described below. We aim to recruit as many patients as possible from the target population, with one of the recruitment strategies producing a 50% enrollment rate.
Who may be able to join
- Age: 18 years or older at time of query
- Visits: 3 non-ED outpatient visits between 1/1/2011 and 12/31/2014
- AF : AF diagnosis documented between 1/1/2011 and 12/31/2014
- AF diagnosis can be coded EHR (on billing or problem lists) and/or derived from EKG reports
- AF diagnoses associated with surgery, certain thyroid conditions, or certain medications cannot count as the qualifying AF diagnosis for inclusion in this cohort.
Who cannot join
- Deceased
- Not proficient in English
- Already enrolled in the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort at another PaTH institution
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Jody McCullough
Hershey, Pennsylvania, 17033
Anuradha Paranjape
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of the PaTH Network AF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients, providers, and other stakeholders.
Read the detailed description
The primary objective is to create the PaTH Network AF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on AF across the multiple institutions of the PaTH network. Creating the AF Clinician-Patient Partnership Cohort will involve:
- Recruiting patients with AF to participate in the PaTH Network AF Clinician-Patient Partnership Cohort
- Administering surveys to the AF Clinician-Patient Partnership Cohort approximately every 6 months to collect patient reported outcomes (PROs)
- Collecting individual patient health record data into the AF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- Identifying potential participants for future research studies.
The secondary objectives are to use the PaTH Network AF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:
- What is the incidence of complications requiring re-hospitalization after an ablation procedure for AF?
- What are the predictors of major bleeding and stroke among patients that receive each anticoagulant class (vit K antagonist, direct factor X inhibitor, direct thrombin inhibitor)?
- Is the longitudinal change in applied cognition-executive function score in AF patients associated with the choice of rate versus rhythm control and anticoagulation strategy?
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Create PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort
Create the PaTH Clinical Data Research Network (CDRN) Atrial Fibrillation (AF) Clinician-Patient Partnership Cohort which will allow the conduct of patient-centered observational studies on atrial fibrillation across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Penn State University, Temple University
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen M McTigue, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485288
- Sponsor's protocol ID
- STUDY20110294
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2015
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Han HR, Jain SK, Naccarelli GV, Aggarwal V, Nazarian S. Association of sex, age and education level with patient reported outcomes in atrial fibrillation. BMC Cardiovasc Disord. 2019 Apr 5;19(1):85. doi: 10.1186/s12872-019-1059-6.
PubMed 30953478Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Jain S, Naccarelli G, Aggarwal V, Nazarian S. Association of sex and atrial fibrillation therapies with patient-reported outcomes. Heart. 2019 Nov;105(21):1642-1648. doi: 10.1136/heartjnl-2019-314881. Epub 2019 May 22.
PubMed 31118198