Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.

NCT ID: NCT02180542

Last Updated: 2017-10-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to improve secondary prevention of ischemic stroke patients by

1. Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation.
2. Characterize ischemic stroke patients by

1. Echocardiographic characteristics
2. Biochemical markers
3. Plaque composition in the carotid arteries

* in order to improve risk stratification.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with atrial fibrillation (AF) have a five-fold increased risk of ischemic stroke compared to the general population. Identifying AF can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of AF. Therefore it is important to identify predictors of AF to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. Few former studies have shown an association between excessive numbers of premature atrial complexes (PACs) and AF.

The study population of ischemic stroke patients will at admission undergo following examinations:

1. ECG
2. 48 hours inpatient cardiac telemetry (If not known AF)
3. 24 hours holter monitoring (if not known AF)
4. echocardiogram
5. blood sample
6. CT scan of carotid arteries with contrast made on Dual Energy CT scan.

In the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) It will be noticed if patients have any recurrent events, die og developing AF.

The study population will be divided into four groups as follows:

1. patients with new AF at admission
2. patients with known AF
3. patients with frequent PACs
4. patients without frequent PACs. These groups will be compared on baseline characteristics and on outcome as mentioned.

The overall perspective is to make better strategies for detecting occult AF after ischemic stroke to improve secondary stroke prevention care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Atrial Fibrillation Premature Atrial Complexes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stroke Ischemic stroke Cerebral infarction recurrent stroke atrial fibrillation premature atrial complexes heart rhythm monitoring left atrial function carotid artery plaque morphology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ischemic stroke patients

Patients admitted with ischemic stroke from march 2012 to april 2014

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* admitted with ischemic stroke at a single center
* time from diagnose to inclusion maximum 7 days.
* written informed consent or surrogate informed consent eligible
* age \> 18 years.

Exclusion Criteria

* hemorrhagic stroke
* terminal illness and expected lifespan of less than 6 months.
* any physical or mental condition which make the patients unsuitable for participation in the study.
* known with a pacemaker
* anticoagulation treatment of other reasons than atrial fibrillation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristina Hoeg Vinther

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristina H Vinther, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Medical Research, OUH, Svendborg

Svendborg, Funen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pacific

Identifier Type: -

Identifier Source: org_study_id