The main aim of this study is investigation of safety and efficacy of platelet- derived mitochondria in heart ischemia
Design
Randomized clinical trial performed on 34 patients with control group, parallel , triple masking in phase I and II clinical trials.
Settings and conduct
This clinical trial study is performed in Heshmat hospital in Rasht.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants, their close relatives or lawyers are able to sign a consent form; Patients with recent myocardial ischemia within 24 hours and candidates for interventional treatment;
Ejection fraction less than or equal to 41%; The age range is between 45-70 years. Exclusion criteria: Patients with mitochondrial disorders; Patients with diabetes; Patients with renal failure; Pregnant women; patients with cancer.
Intervention groups
Intervention group: In the intervention group, platelet derived mitochondria is transplanted through coronary artery by catheter.
Control group: This group receives routine medications and treatments .
Main outcome variables
Cardiac arrhythmia, non-fatal myocardial infarction, fever and shivering, change in vital signs, mortality, re-hospitalization, cardiac enzymes include Cardiac troponin I, Creatin kinase MB.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210920052524N1
Registration date:2021-09-22, 1400/06/31
Registration timing:prospective
Last update:2021-09-22, 1400/06/31
Update count:0
Registration date
2021-09-22, 1400/06/31
Registrant information
Name
Mehryar Habibi Roudkenar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
roudkenar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of safety and efficacy of transplantation of platelet extracted mitochondria in heart ischemic stroke, Clinical trial phase 1 and 2
Public title
Study of safety and efficacy of transplantation of platelet extracted mitochondria in heart ischemic stroke, Clinical trial phase 1 and 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants, their close relatives or lawyers are able to sign a consent form;
Patients with recent myocardial ischemia within 24 hours
Candidate for interventional treatment.
Ejection fraction less than or equal to 41% (EF ≤ 41%).
The age range is between 45-70 years
Both Genders
Exclusion criteria:
Patients with mitochondrial disorders.
Patients with diabetes
Patients with renal failure.
Pregnant women
Patients with cancer are not included in the study.
Age
From 45 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign patients into intervention and control groups, the restricted randomization using block randomization will be used in this study. In order to conceal the last allocated blocks under study, the size of blocks will be consider 4 or 6. To create random numbers, various packages available in R software will be used. Of noted, before the allocation of patients/individuals in the study groups, the allocated group would not be clarified. In order to conceal and confounding factors, allocation concealment will be used. This method will be used for randomization participants in the study. In this study using sealed envelopes in which created randomized sequensces will be recorded on cards, and the cards will be put inside the envelopes respectively. the allocation would be 1:1 ratio.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the participants (patients) would be blinded by sealed envelopes. It should be noted that each created randomized sequences will be recorded on a card, and the cards will be put inside the envelopes respectively.
In order to blind researcher, similar syringes, the same color injection solutions for the control and intervention groups will be used.
The analyzer will also be blinded according to coding of envelope and syringes .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.GUMS.REC.1400.244
Health conditions studied
1
Description of health condition studied
Heart Ischemia
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Cardiac arrhythmia
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
Based on diagnostic tests and physician reports
2
Description
Non-fatal heart ischemia
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
Based on diagnostic tests and physician reports
3
Description
Fever and shivering
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
Thermometer
4
Description
Vital signs change
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
Barometer and diagnostic tests
5
Description
Death
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
Patients records
6
Description
Cardiac enzymes Creatine kinase MB, cardiac troponin I
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
laboratory kits
7
Description
re-hospitalization
Timepoint
24 hours and one week after mitochondrial transplantation
Method of measurement
According to patient file.
Secondary outcomes
1
Description
Left Ventricular Ejection Fraction (LVEF)
Timepoint
3 and 6 months after mitochondrial transplantation
Method of measurement
Echocardiography
2
Description
Left Ventricular End Diastolic Volume Index (LVEDVI)
Timepoint
3 and 6 months after mitochondrial transplantation
Method of measurement
Echocardiography
3
Description
Left Ventricular End Systolic Volume Index (LVESVI)
Timepoint
3 and 6 months after mitochondrial transplantation
Method of measurement
Echocardiography
4
Description
Patient physical activity
Timepoint
3 and 6 months after mitochondrial transplantation
Method of measurement
The Tests such as six-minute walk test and a treadmill test
Intervention groups
1
Description
Intervention group: In the intervention group, platelets derived mitochondrial is transplanted. After preparing the patient, the extracted mitochondria are injected into the coronary artery using a catheter. This group receives all routine interventions similar to control group.
Category
Treatment - Other
2
Description
Control group: This group receives routine medications and treatments such as angioplasty.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Mehryar Habibi Roudkenar
Street address
3 floor, Burn and Regenerative Medicine Research Center, Velayat hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Fax
+98 13 3336 8540
Email
Roudkenar@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Deputy of Research and Technology, Shahid Siadati Street, Namjoo Street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
https://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mehryar Habibi Roudkenar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Regenerative Medicine
Street address
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Fax
+98 13 3336 8540
Email
Roudkenar@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mehryar Habibi Roudkenar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Regenerative Medicine
Street address
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Fax
+98 13 3336 8540
Email
Roudkenar@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mehryar Habibi Roudkenar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Regenerative Medicine
Street address
3th floor, Burn and Regenerative Research Medicine Center, Velayat Hospital, Namjo street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Fax
+98 13 3336 8540
Email
roudkenar@gums.ac.ir
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
Age, sex, cancer incidence, bleeding and side effects
When the data will become available and for how long
What processes are involved for a request to access data/document
The request must be written to the Vice Chancellor for Research of Guilan University of Medical Sciences. The request is sent to the principal investigator and the researcher will send the documents to the deputy. The applicant can receive the documents from the deputy.