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Cognitive Impairment in Atrial Fibrillation (DIAL-F)

This study is currently recruiting participants.
Verified October 2017 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816308
First Posted: March 22, 2013
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation
  Purpose
This study aims to compare the incidence of new-onset cognitive impairments and change in existing impairment status between AF patients undergoing either catheter ablation or remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).

Condition
Atrial Fibrillation Mild Cognitive Impairment Dementia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Mild Cognitive Impairment (MCI) in Patients With Atrial Fibrillation (AF), Trajectories of the Progression of MCI and Factors Associated With the Progression

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up [ Time Frame: 2 years ]
    The primary efficacy endpoint of this study will be the objective response rate (ORR); objective response being defined as improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up.


Secondary Outcome Measures:
  • Correlation between MoCA score and physical activity, social support, anxiety and depression [ Time Frame: 2 years ]
    1. Correlation of scores between the HAD and the social support scale
    2. Correlation of scores between HAD and MoCA
    3. Association between social support and MoCA score
    4. Correlation between physical activity and MoCA scale
    5. Association between arrhythmia recurrence and MoCA score
    6. Comparison of QoL between baseline and post-ablation period


Estimated Enrollment: 888
Study Start Date: July 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Detail study information will be provided to the patients and written informed consent will be obtained from the each patient or family member before enrolling in the study. Consenting patients will be evaluated and the appropriate treatment strategy for managing arrhythmia will be independently determined by the physicians at the participating centers. Patients undergoing catheter ablation for AF will be included in the study group and those determined to stay on AAD will form the control group.
Criteria

Inclusion Criteria:

  1. Age: ≥ 50 years, male or female subjects
  2. Clinical diagnosis of AF
  3. Ability to provide written, informed consent

Exclusion Criteria:

  1. Patients with established dementia
  2. MoCA score ≤ 17 on Montreal Cognitive Assessment (MoCA)
  3. Use of illicit drugs
  4. Alcohol use: >12 drinks/week on average
  5. Clinical evidence of delirium or altered mental status
  6. Medically unstable patients (acute/unstable or poorly controlled problems that would demand focused, relatively urgent or emergent medical attention)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816308


Contacts
Contact: Mitra Mohanty, MD 512-544-8198 mitra.mohanty@stdavids.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty, MD    512-544-8198    mitra.mohanty@stdavids.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD TCAI
Study Director: Mitra Mohanty, MD TCAI
  More Information

Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01816308     History of Changes
Other Study ID Numbers: TCAI_DIAL-F
First Submitted: March 20, 2013
First Posted: March 22, 2013
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
AF
MCI

Additional relevant MeSH terms:
Atrial Fibrillation
Dementia
Cognitive Dysfunction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders