Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke

Ischemic Stroke Clinical Trial

— ASSAM  

Official title:

AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02654795
• Other study ID #: 501-1-10-14-13
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 12, 2016
• Start date: August 2013
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Medical Centre of Postgraduate Education, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Poland	Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre of Postgraduate Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No