- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447002
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex
November 12, 2019 updated by: Burak Cesur, TC Erciyes University
Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines.
Catecholamines may increase in patients with PVC.
Metabolites of catecholamines are metanephrine and normetanephrine.
Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Premature ventricular complex is a very frequent arrhythmia.
Suggested mechanisms for PVCs are reentry, triggered activity, and enhanced automaticity.
Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines.
Catecholamines may increase in patients with PVC.
Half-lives of catecholamines are very short and rather changeable.
Therefore, 24 hours urine levels of catecholamines are the more sensitive than plasma levels.
Metabolites of catecholamines are metanephrine and normetanephrine.
Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kayseri, Turkey
- Erciyes university Yilmaz- mehmet öztaşkın heart hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with % 5 or higher frequents premature ventricular complex in 24 hours rhythm recording will be taken our study.
Description
Inclusion Criteria:
- PVC's rate is more than % 5 in 24 hours rhythm recording
Exclusion Criteria:
- ischemic heart disease
- hyperthyroidism
- patients with low ejection fraction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
metanephrine and normetanephrine levels
Time Frame: about 10 months
|
metanephrine and normetanephrine levels asociated premature ventricular complex frequents
|
about 10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Im SI, Park KM, Park SJ, Kim JS, On YK. New electrocardiographic criteria for predicting successful ablation of premature ventricular contractions from the right coronary cusp. Int J Cardiol. 2016 Dec 1;224:199-205. doi: 10.1016/j.ijcard.2016.09.029. Epub 2016 Sep 16.
- Bradfield JS, Homsi M, Shivkumar K, Miller JM. Coupling interval variability differentiates ventricular ectopic complexes arising in the aortic sinus of valsalva and great cardiac vein from other sources: mechanistic and arrhythmic risk implications. J Am Coll Cardiol. 2014 May 27;63(20):2151-2158. doi: 10.1016/j.jacc.2014.02.551. Epub 2014 Mar 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2018
Primary Completion (ACTUAL)
September 30, 2019
Study Completion (ACTUAL)
September 30, 2019
Study Registration Dates
First Submitted
February 19, 2018
First Submitted That Met QC Criteria
February 24, 2018
First Posted (ACTUAL)
February 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErciyesU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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