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Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke (ASSAM)

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
computed tomography
Sponsored by
Centre of Postgraduate Medical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of ischemic stroke or transient ischemic attack
  • history of AF/AL
  • known status of anticoagulation at the time of stroke (treatment dose, INR level)

Exclusion Criteria:

  • hemorrhagic stroke
  • serious renal impairment with GFR <30 ml/min
  • hyperthyroidism
  • allergy to the contrast agent
  • mental inability to sign the informed consent
  • receptive aphasia

Sites / Locations

  • Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Patients without stroke

Patients with history of stroke

Arm Description

This group will consists of patients scheduled for atrial fibrillation ablation without history of stroke.

This group will consists of patients after ischemic stroke and history of atrial fibrillation.

Outcomes

Primary Outcome Measures

The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
The investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA. The morphology of LAA will be divided into 4 types: the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees the windsock - LAA with one dominant lobe (length > 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm

Secondary Outcome Measures

Full Information

First Posted
January 7, 2016
Last Updated
January 12, 2016
Sponsor
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT02654795
Brief Title
Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke
Acronym
ASSAM
Official Title
AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre of Postgraduate Medical Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients without stroke
Arm Type
Placebo Comparator
Arm Description
This group will consists of patients scheduled for atrial fibrillation ablation without history of stroke.
Arm Title
Patients with history of stroke
Arm Type
Experimental
Arm Description
This group will consists of patients after ischemic stroke and history of atrial fibrillation.
Intervention Type
Radiation
Intervention Name(s)
computed tomography
Intervention Description
CT angiography will be performed with a dual-source CT scanner using prospective ECG gating, with detector collimation of 128x0.6 mm, a gantry rotation time of 280 ms, tube voltage of 100-120 kV, tube current of 280-380 mAs depending on the patient's body mass.
Primary Outcome Measure Information:
Title
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
Description
The investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA. The morphology of LAA will be divided into 4 types: the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees the windsock - LAA with one dominant lobe (length > 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of ischemic stroke or transient ischemic attack history of AF/AL known status of anticoagulation at the time of stroke (treatment dose, INR level) Exclusion Criteria: hemorrhagic stroke serious renal impairment with GFR <30 ml/min hyperthyroidism allergy to the contrast agent mental inability to sign the informed consent receptive aphasia
Facility Information:
Facility Name
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59
City
Warsaw
ZIP/Postal Code
04 073
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Kulakowski, MD, PhD
Phone
0048602655728
Email
pkulak@kkcmkp.pl
First Name & Middle Initial & Last Name & Degree
Jakub Baran, MD,PhD
Phone
0048697604544
Email
j.baran@sampi.pl
First Name & Middle Initial & Last Name & Degree
Jakub Baran, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke

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