NCT02654795

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

January 7, 2016

Last Update Submit

January 12, 2016

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion, an average of 1 year

Study Arms (2)

Patients without stroke

PLACEBO COMPARATOR

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

Radiation: computed tomography

Patients with history of stroke

EXPERIMENTAL

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

Radiation: computed tomography

Interventions

computed tomographyRADIATION

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.

Patients with history of strokePatients without stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, 04 073, Poland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 13, 2016

Study Start

August 1, 2013

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)