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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02374359
Other study ID # CPTCAR-EP201501
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 23, 2015
Last updated February 26, 2015
Start date January 2015
Est. completion date February 2015

Study information

Verified date February 2015
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority Spain: CEIC Corporacio Sanitaria Parc Tauli
Study type Observational

Clinical Trial Summary

There is few information about the association between supraventricular arrhythmia different from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the investigators hypothesized that the presence of atrial tachycardia would lead to atrial fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.

The investigators study the association of atrial tachycardia (AT), defined as four or more consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in 192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12 months for all population


Description:

The investigators review all consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge. All patients routinely underwent 24-hour ECG recording and an echocardiography during the hospitalization. The investigators have a global population of 210 patients who met these characteristics.

The investigators analyze the presence of atrial tachycardia in 24-hour ECG register in patients with cryptogenic stroke. The investigators consider atrial tachycardia as four or more consecutive atrial ectopic beats.

The investigators analyze baseline characteristics (cardiovascular risk factors, renal function, left atrial size _measured in M mode echocardiography in long paraesternal axis_ and total number of premature atrial complexes in the 24-hour ECG monitoring.

The patients are stratified according to the presence or absence of atrial tachycardia in 24-hour ECG data.

The investigators follow the clinical events (AF, recurrent stroke or death) of patients from the electronical medical data of general physician and the re-hospitalizations for recurrent ictus in our hospital (which is the reference hospital of the zone) and mortality during 12 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 210
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge

Exclusion Criteria:

- Patients with non-cryptogenic stroke

- Patients with haemorragic stroke

- Patients with terminal disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Other:
follow-up


Locations

Country Name City State
Spain Corporacio Sanitaria Parc Tauli Sabadell Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary ischemic stroke 12 months No
Secondary atrial fibrillation 12 months No
Secondary cardiovascular mortality 12 months No
Secondary global mortality 12 months No
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