Left Atrial Function in Recurrent Stroke of Unknown Cause

NCT02968329 | Completed

• 1 other identifier: JJBV544
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is an important cause of disability and the third leading cause of death. Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). There have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke. Recent studies have suggested that left atrial (LA) function is an important determinant of stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to investigate other echocardiographic parameters. The aim of this study is to assess the predictive value of left atrial function for the risk of stroke recurrence and/or atrial fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven atrial fibrillation (AF) and no indication for anticoagulants.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Recurrent ischemic CVA or TIA

  Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years

  up to four years

Secondary Outcomes (1)

• 'New' diagnosis of AF

  Up to four years

Study Arms (4)

CVA cases

patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence.

CVA controls

patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence.

AF cases

patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF

AF controls

patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Cryptogenic Stroke

You may qualify if:

• CVA
• TIA

You may not qualify if:

• proven AF or atrial flutter
• prior ablation for AF
• valvular disease
• artificial heart valves
• endocarditis
• presence of an atrial septum defect or moderate to large patent foramen ovale
• LV akinesia
• moderate to severe carotid stenosis
• prior surgery for carotid artery stenosis
• total occlusion of the internal carotid artery
• carotid artery dissection
• vertebral artery dissection
• massive aortic atheromatosis
• temporal arteritis
• basilar artery aneurysm

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul Dendale, prof. dr.

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

• Bram Verdonck, student

  Hasselt University

  STUDY CHAIR

• Jens Jeurissen, student

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 18, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

BE (1)