NCT03824509

Brief Summary

The goal is to review patients with known atrial fibrillation who suffered a stroke or transient ischemic attack (TIA) to incorporate any structural heart abnormalities into the overall clinical picture. A better understanding of the additional risk of a stroke or TIA in patients with specific structural abnormalities may be beneficial in guiding future treatment decisions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

July 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

January 29, 2019

Last Update Submit

July 12, 2021

Conditions

Atrial FibrillationStroke

Keywords

riskCHA2DS-VASc score

Outcome Measures

Primary Outcomes (2)

  • Left atrial volume

    1)Assess left atrial volume using volumetric measurements and left ventricular septal and posterior wall thickness from 2-D transthoracic echocardiography studies in patients with known atrial fibrillation who suffered a stroke or TIA. We would then compare these data to control patients with atrial fibrillation with matched CHA2DS2-VASc scores, age (+/- 5 years), and gender who have no history of stroke or TIA.

    12 months

  • Stroke outcome

    Compare structural changes found on echocardiogram to stroke severity, as measured by NIH Stroke Scale and/or Rankin Score.

    12 months

Study Arms (2)

Patients with an echocardiagram who suffered a stroke or TIA

1. Medical record number 2. Sex 3. Age 4. BMI 5. Body surface area 6. Smoking status 7. Congestive heart failure 8. Hypertension 9. Diabetes, 10. Previous history of heart attack or vascular disease 11. Previous history of stroke 12. Date of stroke 13. Type of stroke 14. CHA2DS2-VASc scores 15. On an anticoagulant yes/no at time of stroke 16. Date of atrial fibrillation diagnosis 17. Date of echocardiogram 18. Echocardiographic features: a. Left atrial volume, indexed to body surface area (BSA) b. Left ventricular hypertrophy 4. Stroke outcome: 1. Mortality 2. NIH Stroke Scale 3. Modified Rankin Scale 4. Discharge placement: i. Home ii. Long term care iii. Skilled nursing facility e. 6-month survival

Other: Chart Review

Control Group - matched CHA2DS2-VASc score, age, and gender

Controls from both PBMC and MMC will be obtained. Controls are patients from 2014-2017 with matched age (+/- 5 years), gender, and CHA2DS2-VASc score who had atrial fibrillation and had not had a documented stroke or TIA in EPIC or the "Get with the Guidelines" registry maintained at PBMC. Controls must have an echocardiogram on record and have a diagnosis of atrial fibrillation at the time of the echocardiogram.

Other: Chart Review

Interventions

Chart ReviewOTHER

Study staff at PBMC (Cardiologist and two clinical researchers) will be responsible for maintaining all data related to this study in REDCap. Patient data to be included in this secondary data analysis will originate from MMC and PBMC. Case-patient data to be included from MMC will be identified by an EPIC data request from Enterprise Reporting. The elements of the data request will be patients who have had a stroke or TIA, atrial fibrillation, and a transthoracic echocardiogram at MMC from 2014-2017.

Control Group - matched CHA2DS2-VASc score, age, and genderPatients with an echocardiagram who suffered a stroke or TIA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with known atrial fibrillation who suffered a stroke or transient ischemic attack (TIA) and matched controls with matched age (+/- 5 years), gender, and CHA2DS2-VASc score who had atrial fibrillation and had not had a documented stroke or TIA in EPIC or the "Get with the Guidelines" registry maintained at PBMC. Controls must have an echocardiogram on record and have a diagnosis of atrial fibrillation at the time of the echocardiogram.

You may qualify if:

  • Diagnosis of stroke or TIA
  • Atrial fibrillation
  • Transthoracic echocardiogram
  • CHA2DS2-VASc score of 0, 1, or 2
  • Patients with matched age (+/- 5 years), gender, and CHA2DS2-VASc score
  • Atrial fibrillation
  • No stroke or TIA

You may not qualify if:

  • \- Patients with a CHA2DS2-VASc score greater than 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pen Bay Medical Center

Rockport, Maine, 04856, United States

Location

Related Publications (4)

  • January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.

    PMID: 24682347BACKGROUND

  • Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. 1991 Aug;84(2):527-39. doi: 10.1161/01.cir.84.2.527.

    PMID: 1860198BACKGROUND

  • Barnes ME, Miyasaka Y, Seward JB, Gersh BJ, Rosales AG, Bailey KR, Petty GW, Wiebers DO, Tsang TS. Left atrial volume in the prediction of first ischemic stroke in an elderly cohort without atrial fibrillation. Mayo Clin Proc. 2004 Aug;79(8):1008-14. doi: 10.4065/79.8.1008.

    PMID: 15301328BACKGROUND

  • Badheka AO, Shah N, Grover PM, Patel NJ, Chothani A, Mehta K, Singh V, Deshmukh A, Savani GT, Rathod A, Panaich SS, Patel N, Arora S, Bhalara V, Coffey JO, Mitrani RD, Halperin JL, Viles-Gonzalez JF. Outcomes in atrial fibrillation patients with and without left ventricular hypertrophy when treated with a lenient rate-control or rhythm-control strategy. Am J Cardiol. 2014 Apr 1;113(7):1159-65. doi: 10.1016/j.amjcard.2013.12.021. Epub 2014 Jan 14.

    PMID: 24507168BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

January 1, 2019

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

July 16, 2021

Record last verified: 2021-03

Locations

US(1)