Atrial FibrillationNCT03824509
Echocardiographic Risk Factors of Stroke in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation and Stroke, run by MaineHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Chart Review
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 21 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with a CHA2DS2-VASc score greater than 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiographic Risk Factors of Stroke in Patients With Atrial
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.
Read the detailed description
Atrial fibrillation is the most common heart rhythm disorder seen in clinical practice. Patients with atrial fibrillation are at increased risk for stroke. This risk is determined by several factors. Congestive heart failure, hypertension, age, diabetes, female sex, previous history of heart attack or vascular disease, and previous history of stroke all increase a patients' risk for clot formation and stroke. These risk factors have been formulated into a scoring system called the CHA2DS2-VASc score. A score of greater than 2 on this scale indicates a moderate to high risk for clot formation and stroke. Anticoagulation medications are recommended in these patients. Non-traditional risk factors such as left atrial size and left ventricular hypertrophy have also been associated with increased stroke risk. These factors have not yet been routinely incorporated into treatment decisions regarding anticoagulation and stroke prevention.
This study is an expansion of an initial pilot conducted at Pen Bay Medical Center of patient records from 2014-2017. This pilot found 19 patients with a recorded stroke or TIA, history of atrial fibrillation, and CHA2DS2-VASc score of 2 or lower within that time period. This study will be an expansion of that pilot to include patient data from Maine Medical Center.
This study aims to look at these non-traditional risk factors in patients who have an otherwise low stroke risk based on the CHA2DS2-VASc score.
Our specific aims are:
- 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. The investigator 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. The goal is to identify higher risk patients with alternate anatomy who otherwise would be considered lower risk using traditional risk scoring methods. Identifying these individuals may lead to more aggressive interventions and subsequently may help in reducing the risk of stroke.
- Assess stroke outcome as measured by NIH Stroke Scale and/or Modified Rankin Scale score, in the population of patients with atrial fibrillation who suffered a stroke to identify any potential differences associated with structural changes. If structural changes are associated with stroke severity, echocardiogram findings again may aid in guiding treatment decisions for patients with atrial fibrillation.
Hypothesis: Patients with atrial fibrillation and a history of stroke or TIA will have alternate anatomy when compared to patients with atrial fibrillation with matched CHA2DS2-VASc scores who have not had a stroke or TIA.
This is a retrospective matched case-control study of data collected at Pen Bay Medical Center (PBMC) and Maine Medical Center (MMC) from 2014-2017. Patient records that met the criteria as a case from PBMC have already been collected from existing data housed in the American Heart Association's "Get with the Guidelines" registry as a pilot project. These data will be included in this study and combined with controls identified from PBMC, and cases and controls identified from existing EPIC data for MMC patients.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Chart Review
- Keywords
- risk, CHA2DS-VASc score
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Stroke outcome
Compare structural changes found on echocardiogram to stroke severity, as measured by NIH Stroke Scale and/or Rankin Score.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jan 2019
- Primary completion21 May 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824509
- Sponsor's protocol ID
- GelwixECHO
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2019
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24682347Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. 1991 Aug;84(2):527-39. doi: 10.1161/01.cir.84.2.527.
PubMed 1860198Barnes 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.
PubMed 15301328Badheka 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.
PubMed 24507168