Comparative study of the frequency of complications due to high-risk pulmonary thromboembolism after rapid performance of the team responsible for pulmonary embolism (TIMAR) compared to conventional performance
Comparative study of the frequency of complications due to high-risk pulmonary thromboembolism after rapid performance of the team responsible for pulmonary embolism (TIMAR) compared to conventional performance
Design
Clinical trial with control group with parallel groups, phase 2-3 on 74 patients
Settings and conduct
This study is performed in Shahid Chamran Hospital in Isfahan. Patients will be treated in two ways and the mortality rate, complications and cardiac function will be compared between groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 75 years old; diagnosis of pulmonary thromboembolism based on the GENEVA criteria; patients with high-risk pulmonary embolism; satisfaction with entering this study.
Exclusion criteria: dissatisfaction with continue participation in the study.
Intervention groups
Intervention group: Patients in this group, whose thromboembolism has been previously proven by CT scan and Geneva criteria, are visited and evaluated by a cardiology resident and treated if patients are at high risk for thromboembolism, they will be treated according to the protocol provided by the Timar team members and the treatment plan will be implemented within a maximum of 60 minutes. Mortality and treatment complications as well as cardiac function in patients after interventions will be measured by echocardiography and checklist.
Control group: patients in this group, as usual and according to hospital protocols, will be examined by a cardiology resident and their thromboembolism will be diagnosed by CT scan and Geneva criteria and will be treated by the cardiology service. Mortality and treatment complications as well as cardiac function in patients after interventions will be measured by echocardiography and checklist.
Main outcome variables
The mortality rate; complications and cardiac function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210613051561N1
Registration date:2021-06-21, 1400/03/31
Registration timing:prospective
Last update:2021-06-21, 1400/03/31
Update count:0
Registration date
2021-06-21, 1400/03/31
Registrant information
Name
farid esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 0897
Email address
farid.esmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-05, 1400/05/14
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the frequency of complications due to high-risk pulmonary thromboembolism after rapid performance of the team responsible for pulmonary embolism (TIMAR) compared to conventional performance
Public title
Complications of pulmonary thromboembolism after rapid performance of the team responsible for pulmonary embolism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years old
Diagnosis of pulmonary thromboembolism based on the GENEVA criteria
Patients with high-risk pulmonary embolism
Satisfaction with entering this study
Exclusion criteria:
Dissatisfaction to continue participation in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
N/A
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.MUI.MED.REC.1398.367
Health conditions studied
1
Description of health condition studied
Pulmonary embolism
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
Mortality rate
Timepoint
After interventions
Method of measurement
Check list
2
Description
Time of hospitalization
Timepoint
After interventions
Method of measurement
Check list
3
Description
Heart function
Timepoint
After interventions
Method of measurement
Eco cardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in this group, whose thromboembolism has been previously proven by CT scan and Geneva criteria, are visited and evaluated by a cardiology resident and treated if patients are at high risk for thromboembolism, they will be treated according to the protocol provided by the Timar team members and the treatment plan will be implemented within a maximum of 60 minutes. Mortality and treatment complications as well as cardiac function in patients after interventions will be measured by echocardiography and checklist.
Category
Treatment - Other
2
Description
Control group: patients in this group, as usual and according to hospital protocols, will be examined by a cardiology resident and their thromboembolism will be diagnosed by CT scan and Geneva criteria and will be treated by the cardiology service. Mortality and treatment complications as well as cardiac function in patients after interventions will be measured by echocardiography and checklist.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Mohammad Hadi Mansouri
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mansouri.hadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mansouri.hadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mansouri.hadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mansouri.hadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.