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

Centre of Postgraduate Medical Education

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Radiation: computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02654795

501-1-10-14-13

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Patients without stroke

Placebo Comparator group

Description:

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

Treatment:

Radiation: computed tomography

Patients with history of stroke

Experimental group

Description:

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

Treatment:

Radiation: computed tomography