Determination the efficacy of curcumin in preventing heart failure after acute myocardial infarction
Design
This is a double blind prospective placebo controlled clinical trial study which can performed in Quam hospital, Mashhad.
Settings and conduct
double blind prospective placebo controlled clinical trial study
Participants/Inclusion and exclusion criteria
patients between 18 and 80 years with STEMI who underwent successful revascularisation on culprit vessel will be included.
Patients with previous MI which was lead to ejection fraction less than 50%, malignant ventricular arrhythmia, congenital heart disease, cardiogenic shock, history of suspicious or documented heart failure or decrease in left ventricular ejection fraction, patients candidate for CABG or history of previous CABG, patients with GFR less than 30, patients with autoimmune or connective tissue disorders, subjects with cancer, pregnant or breastfeeding women, psychological patients and persons who can not complete 2-month clinical followup during study, will be excluded.
Intervention groups
Group receiving curcumin and Group receiving placebo
Main outcome variables
Left ventricular ejection fraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130829014521N19
Registration date:2022-02-19, 1400/11/30
Registration timing:registered_while_recruiting
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of curcumin effect on preventing heart failure after myocardial infarction
Public title
Effect of curcumin on preventing heart failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ST elevation myocardial infarction
Successful treatment with percutaneous coronary intervention (PCI) on related vessel to infarct
Exclusion criteria:
Previous myocardial infarction lead to ejection fraction less than 50%
malignant arrhythmia
congenital heart disease
cardiogenic shock
history of suspicious or documented heart failure or decrease in left ventricular ejection fraction
patients candidate for coronary artery bypass graft (CABG) or previous CABG
patients with glomerular filtration rate lesser than 30
patients with history of autoimmune or connective tissue disorders
patients with cancer
pregnant or breastfeeding women
patients with previous documented psychological disorders
patients who can not complete their 2-month clinical followups during study
Age
From 18 years old to 80 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to 500mg capsule of curcumin (500mg daily) or placebo capsule, by block randomization with block size of 2. In each block, patients of each group will be exist. The order of blocks will be determined randomly in 500mg capsule of curcumin (500mg daily) and placebo capsule groups and subjects will allocated sequentially with order of admitting. Random allocation rule method was used for determination of sequences. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done by complete matching of placebo and drugs by color, size, shape and smell. Patients receive drugs (intervention or placebo groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and evaluator nurse will be blind for type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Mashhad University of Medical Sciences
Street address
Qoreshi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-04-17, 1398/01/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.003
Health conditions studied
1
Description of health condition studied
ST elevation myocardial infarction
ICD-10 code
BA41.0
ICD-10 code description
BA41
Primary outcomes
1
Description
Left ventricular ejection fraction
Timepoint
baseline and 60 days later
Method of measurement
By echocardiography
Secondary outcomes
1
Description
Major adverse cardiovascular events
Timepoint
during hospitalization and 60 days after starting study
Method of measurement
documents and reports of cardiac death, recurrent MI, culprit vessels revascularisation, cardiogenic shock, severe heart failure, major arrhythmia
Intervention groups
1
Description
Intervention group: curcumin capsule 500 mg
Category
Treatment - Drugs
2
Description
Control group: placebo capsule 500mg
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
SARA KHAKI
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 935 457 4977
Email
KHAKIS991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Qoresh
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
sahebkara@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ramin Khameneh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ghaem hospital, Mashhad city, IRan
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 1800 2288
Email
khamenehR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Medicine, Vakilabad blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 1882 9260
Fax
+98 51 1882 3251
Email
sahebkara@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not 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
After finishing the study, results will be published as article.
When the data will become available and for how long
unlimited
To whom data/document is available
Researchers, Physicians, Pharmacists
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
request to corresponding author
What processes are involved for a request to access data/document
Sending request to corresponding author and explain the cause of request. If it was confirmed, it will be sent.