Cryptogenic StrokeNCT02374359
Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by Corporacion Parc Tauli at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cryptogenic Stroke, Atrial Fibrillation, Atrial Tachycardia
- What is being tested?
- follow-up
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We 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
Who may be able to join
- 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
Who cannot join
- Patients with non-cryptogenic stroke
- Patients with haemorragic stroke
- Patients with terminal disease
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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.
- Conditions
- Cryptogenic Stroke, Atrial Fibrillation, Atrial Tachycardia
- Being tested
- follow-up
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| atrial tachycardia group | Patients diagnosed of cryptogenic stroke with atrial tachycardia in holter Receives: Other: follow-up | |
| Non atrial tachycardia group (control group) | Patients diagnosed of cryptogenic stroke with a normal holter Receives: Other: follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke
Measured: 12 months
Secondary outcomes (3)
atrial fibrillation
Measured: 12 months
cardiovascular mortality
Measured: 12 months
global mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabet Pujol-Iglesias, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374359
- Sponsor's protocol ID
- CPTCAR-EP201501
- Status last verified
- Feb 2015
- First submitted
- 23 Feb 2015
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke
- ClinicalTrials.gov ID
- NCT02374359
- Acronym / sponsor ID
- CPTCAR-EP201501
- Conditions
- Cryptogenic Stroke, Atrial Fibrillation, Atrial Tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atrial tachycardia group | – | Other: follow-upPatients diagnosed of cryptogenic stroke with atrial tachycardia in holter |
| Non atrial tachycardia group (control group) | – | Other: follow-upPatients diagnosed of cryptogenic stroke with a normal holter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with non-cryptogenic stroke
- Patients with haemorragic stroke
- Patients with terminal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up | Other | Non atrial tachycardia group (control group), atrial tachycardia group |
Primary outcome
ischemic stroke
Time frame: 12 months
3 secondary outcomes
atrial fibrillation
Time frame: 12 months
cardiovascular mortality
Time frame: 12 months
global mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.