Determining the recurrence rate of supraventricular arrhythmias after taking dobutamine compared to isoproterenol
Design
کارآزمایی بالینی در دوگروه مداخله ای بدون تصادفی سازی وکور سازی روی 400 بیماران در فاز 3
Settings and conduct
Heart Department of Saadi's Hospital
Participants/Inclusion and exclusion criteria
All patients underwent ablation
Intervention groups
Dobutamine and isoproterenol
Main outcome variables
Re-ablation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230918059453N1
Registration date:2023-10-16, 1402/07/24
Registration timing:prospective
Last update:2023-10-16, 1402/07/24
Update count:0
Registration date
2023-10-16, 1402/07/24
Registrant information
Name
Leila Jamali
Name of organization / entity
Shoshtari Hospital
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2320
Email address
jamalileila1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
arrhythmia Induction using isoproterenol or dobutamine during electrophysiology study for supra-ventricular arrhythmia
Public title
Induction of supra-ventricular arrhythmias dobutamine vs isoprotrenole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients underwent ablation
Exclusion criteria:
All patients are included in the study and there are no conditions for non-entry.
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Blvd ,Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-05-21, 1402/02/31
Ethics committee reference number
IR.SUMS.REC.1402.100
Health conditions studied
1
Description of health condition studied
Cardiac arrhythmia, unspecified
ICD-10 code
I49.9
ICD-10 code description
Cardiac arrhythmia, unspecified
Primary outcomes
1
Description
Recurrence arrhythmia
Timepoint
1, 3, and 6 months after the intervention
Method of measurement
Based on recurrence of arrhythmia and need to anti arrhythmic drug or ablation
Secondary outcomes
1
Description
recurrence of chest pain and arrhythmia
Timepoint
1,3,6 mount
Method of measurement
underwent ECG by cardiologist
Intervention groups
1
Description
Intervention group 1: Dobutamine - by injection once at the beginning of the study. At the beginning of the study, 15 micrograms of dobutamine drug were injected to the people in this group.
Category
Treatment - Drugs
2
Description
Intervention group 2: Isoproterenol - by injection once at the beginning of the study. At the beginning of the study, 15 micrograms of isoproterenol was injected into the people in this group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Saadi's Hospital
Full name of responsible person
Mohammad Hossein Niko
Street address
Blvd Zand
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2320
Email
jamalileila1989@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hashem Hashempour
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2320
Email
jamalileila1989@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2320
Email
jamalileila1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2320
Email
jamalileila1989@gmail
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Jamali
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2320
Email
jamalileila1989@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data can be published if you have the permission of the vice president of research
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Research Vice President of Shiraz University of Medical Sciences
Under which criteria data/document could be used
In order to reanalyze
From where data/document is obtainable
Leila Jamali
What processes are involved for a request to access data/document