Assessment of left ventricular function by global longitudinal strain to detect subclinical Cardiomyopathy early after Busulfan therapy in patients undergoing bone marrow allogeneic transplantation
Assessment of left ventricular global longitudinal strain to detect subclinical Cardiomyopathy early after Busulfan therapy
Design
Single_arm clinical trial design of 14 patients,enroled between september 2017 and march 2018
Settings and conduct
Pateints undergoing Allogenic bone marrow transplant at Taleghani hospital assessed by a single
operator ,by Simensce Prime [ACUSON SC2000]
machine. Vector velocity imaging (VVI) method was utilized to calculate the global longitudinal strain component in 16 left ventricular segments and 3 persistent cardiac cycles. left ventricular Global Longitudinal Strain was mesured before and after Busulfan therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria :patients undergoing Allogenic bone marrow transplantation
exclusion criteria :DM,HTN,Hyperlipidemia,Smoking,major valvular heart dis,CKD, initial EF less than 55%
Intervention groups
Echocardiograghy was done for Pateints undergoing bone marrow transplantation at the begining of the study.Busulfan dose was 0.8 mg/kg with intravenus infusion during two hours quarterly in four consecutive days; attaining 16 doses.After 7 days of Busulfan therapy patient was assessed again by the same operator.
Main outcome variables
Left ventricular Global longitudinal strain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191230045950N1
Registration date:2020-01-18, 1398/10/28
Registration timing:retrospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Seyede houra Yeganegi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 3881
Email address
sarvenaz_yeganegi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
2018-03-20, 1396/12/29
Scientific title
Assessment of left ventricular function by global longitudinal strain to detect subclinical Cardiomyopathy early after Busulfan therapy in patients undergoing bone marrow allogeneic transplantation
Public title
Effect of Busulfan in left ventricular global lingitudinal strain
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing allogenic bone marrow transplantation
Exclusion criteria:
Diabetes melitus
Hypertension
Smoking
Family history of Ischemic heart disease
Major valvular heart disease
Hyperlipidemia
CKD
Obesity
Initial ejection fraction less than 55%
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti university of Medical Sciences
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Aarabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
Ir.sbmu.msp.rec.1396.664
Health conditions studied
1
Description of health condition studied
Cardiomyopathy
ICD-10 code
I42
ICD-10 code description
Cardiomyopathy
Primary outcomes
1
Description
Left ventricular function by Global longitudinal strain (GLS)
Timepoint
At the begining of the study and 7 days after Busulfan therapy
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Left ventricular end diastolic volume
Timepoint
At the begining and 7 days after Busulfan therapy
Method of measurement
Echocardoography
2
Description
Left ventricular end systolic volume
Timepoint
At the begining and 7 days after Busulfan therapy
Method of measurement
Echocardiography
3
Description
Left ventricular ejection fraction
Timepoint
At the begining and 7 days after Busulfan therapy
Method of measurement
Echocardiograghy
Intervention groups
1
Description
Intervention group:Echocardiograghy was done for Pateints undergoing bone marrow transplantation at the begining of the study and then 7 days after Busulfan therapy .Busulfan dose was 0.8 mg/kg with intravenus infusion during two hours quarterly in four consecutive days; attaining 16 doses.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Seyede Houra yeganegi
Street address
Taleghani Hospital, Aarabi Ave., Yaman Ave., Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
taleghani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 Shahid Beheshti University of Medical Sciences, Aarabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Yousef Qoddossi
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Taleghani Hospital, Yaman Ave., Aarabi Ave., Chamran Highway, Tehran