Mild Cognitive Impairment (MCI) in Patients With Atrial Fibrillation (AF), Trajectories of the Progression of MCI and Factors Associated With the Progression (DIAL-F)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01816308
First received: March 20, 2013
Last updated: July 31, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01816308     History of Changes
Other Study ID Numbers: TCAI_DIAL-F
Study First Received: March 20, 2013
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
AF
MCI

Additional relevant MeSH terms:
Mild Cognitive Impairment
Atrial Fibrillation
Disease Progression
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 16, 2014