Extended Rhythm SCreening for AtRial Fibrillation in Cryptogenic Stroke Patients

NCT01550042 | Terminated DMC

• 2 other identifiers: NL36491.044.11P11-25
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies demonstrated that prolonged rhythm observation increases the detection of atrial fibrillation in patients prior diagnosed as cryptogenic stroke. Detection of atrial fibrillation in these patients has important therapeutic implications for the anticoagulation regimen. However, data on optimal monitoring duration and method of AF detection are limited.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• Documented Atrial Fibrillation (AF)

  The percentage of patients with documented AF based on implantable cardiac monitor registration during a follow-up period of at least 12 months after an episode of cryptogenic stroke.

  One year

Secondary Outcomes (2)

• Time to documented AF

  One year

• Recurrent stroke

  One year

Study Arms (1)

Intensive observation cohort

Patients \> 18 years of age diagnosed with a recent episode of cryptogenic stroke with long term rhythm observation using an implantable loop recorder for detecting atrial fibrillation.

Eligibility Criteria

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

Study Population

Patients admitted with a ischemic stroke of undetermined etiology

You may qualify if:

• Patients \> 18 years of age Recent episode (≤60 days) of cryptogenic ischemic stroke
• Undetermined etiology with negative evaluation (including cardioembolism work- up) according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST)
• Implantation of an implantable loop recorder within two months after index event
• Able of providing informed consent

You may not qualify if:

• Pre-existing indication for vitamin K antagonist
• Untreated hyperthyroidism
• Indication for pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT)
• Severe co-morbidity not likely to complete follow-up for one year

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente / Thoraxcenter

Enschede, Overijssel, NL7513ER, Netherlands

Location

Related Links

• Thoraxcenter

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Marcoen Scholten, MD PhD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow electrophysiology

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

NL (1)