Arrhytmia in PsoriasisNCT02045485
P Wave and QT Dispersion in Psoriasis
An observational study of Arrhytmia in Psoriasis, run by Yuzuncu Yil University.
Trial summary
Background: Several reports have demonstrated an association between psoriasis and cardiovascular diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers used to evaluate the risk of atrial arrhythmias. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrhytmia in Psoriasis
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2006
- How long will I take part?
- 6 Months
- 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 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy.
Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded.
About this study
Official title: Increased Risk of Atrial and Ventricular Arrhythmia in Long-lasting Psoriasis
Background:
Several reports have demonstrated an association between psoriasis and cardiovascular diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.
Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area and Severity Index (PASI).
Read the detailed description
Ninety-four outpatient psoriasis patients and 51 healthy people were included in the study. Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded. Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy. Severity of the psoriasis was evaluated by psoriasis area and severity index (PASI). Patients were evaluated by physical examination, 12-lead electrocardiography and transthoracic echocardiography.
- Conditions
- Arrhytmia in Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of p wave and QT interval
Measured: 3 -360 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2006
- Primary completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhytmia in PsoriasisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hakki simsek, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045485
- Sponsor's protocol ID
- 901215
- Status last verified
- Jan 2014
- First submitted
- 26 Feb 2013
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Risk of Atrial and Ventricular Arrhythmia in Long-lasting Psoriasis
- ClinicalTrials.gov ID
- NCT02045485
- Acronym / sponsor ID
- 901215
- Conditions
- Arrhytmia in Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2006 (actual)
- First posted
- 24 Jan 2014 (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.
Background:
Several reports have demonstrated an association between psoriasis and cardiovascular diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.
Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area and Severity Index (PASI).
Detailed description
Ninety-four outpatient psoriasis patients and 51 healthy people were included in the study. Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded. Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy. Severity of the psoriasis was evaluated by psoriasis area and severity index (PASI). Patients were evaluated by physical examination, 12-lead electrocardiography and transthoracic echocardiography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration of p wave and QT interval
Time frame: 3 -360 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhytmia in Psoriasis, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
duration of p wave and QT interval (time frame: 3 -360 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 24 Jan 2014.