Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke

NCT ID: NCT02654795

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients without stroke

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

Group Type PLACEBO_COMPARATOR

computed tomography

Intervention Type RADIATION

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 stroke

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

Group Type EXPERIMENTAL

computed tomography

Intervention Type RADIATION

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.

Interventions

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computed tomography

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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Jakub Baran MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Piotr Kulakowski, MD, PhD

Role: primary

0048602655728

Jakub Baran, MD,PhD

Role: backup

0048697604544

Other Identifiers

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501-1-10-14-13

Identifier Type: -

Identifier Source: org_study_id

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