Evaluation of the effectiveness of Curcumin in the prevention of Peri-procedural Myocardial Injury (PPMI) in patients undergoing Percutaneous Coronary Intervention (PCI) referred to Imam Ali Research Hospital Zahedan
Design
A randomized clinical trial with placebo and treatment with Curcumin groups, 2 Blinded, including 108 patients
Settings and conduct
This study will be performed on 108 patients undergoing PCI referred to Imam Ali Research Hospital in Zahedan city. Patients in the Curcumin treatment group will receive the PCI standard pretreatment protocol (aspirin, and Clopidogrel) along with Curcumin administration (1000mg- 3 days before PCI) and in the placebo group will receive the PCI standard pretreatment protocol with placebo (with the same duration). Finally, serum levels of High-Sensitivity Troponin-I (hs-Troponin-I) and High-Sensitivity C-reactive protein (hs-CRP) will be measured in 2 time periods before PCI and 24 hours after PCI to determine the effect of Curcumin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 18 to 80 years, Patients with ischemic heart disease or acute coronary syndrome who referred for coronary angiography with a possible clinical indication for PCI. Exclusion criteria: Severe Hepatic dysfunction (AST or ALT more than 3 times UMN), Renal dysfunction (serum creatinine more than 2.5 mg/dL or undergoing dialysis), History of revascularization (PCI or CABG).
Intervention groups
Placebo group: patient with standard PCI pretreatment protocol with placebo for 3 days before PCI, Experimental group: patient with standard PCI pretreatment protocol with 1000mg Curcumin for 3 day before PCI
Main outcome variables
High-Sensitivity Troponin-I (hs-Troponin-I), High-Sensitivity C-reactive protein (hs-CRP), stent thrombosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231125060174N1
Registration date:2023-12-08, 1402/09/17
Registration timing:prospective
Last update:2023-12-08, 1402/09/17
Update count:0
Registration date
2023-12-08, 1402/09/17
Registrant information
Name
Kaveh OraiiYazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 2040
Email address
dr.k.o.yazdani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin in the prevention of Peri-procedural Myocardial Injury following Percutaneous Coronary Intervention (PPMI)
Public title
Effect of Curcumin in the prevention of Peri-procedural Myocardial Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ischemic heart disease and candidates for PCI or acute coronary syndrome who referred for coronary angiography with a possible clinical indication for PCI
Patients with acute coronary syndrome and candidates for PCI
Patients have undergone elective and non-emergency PCI
Consent to participate in the present study
Exclusion criteria:
using the oral steroid drugs or NSAIDs except aspirin
Active malignancy or infection
History of Myelodysplasia
Severe Hepatic dysfunction (AST or ALT more than 3 times UMN)
Pregnancy
Renal dysfunction (serum creatinine more than 2.5 mg/dL or undergoing dialysis)
History of revascularization (PCI or CABG)
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
People have been blinded: Participant and Data analyzer
Curcumin and placebo are completely similar in shape, color and administration method
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
۹۸۱۶۷۴۳۱۱۱
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.ZAUMS.REC.1402.306
Health conditions studied
1
Description of health condition studied
Peri-procedural Myocardial Injury
ICD-10 code
S26.9
ICD-10 code description
Injury of heart, unspecified with or without hemopericardium
Primary outcomes
1
Description
serum levels of hs-Troponin-I
Timepoint
before PCI and 24 hours after PCI
Method of measurement
Immunoassay
2
Description
serum levels of hs-CRP
Timepoint
before PCI and 24 hours after PCI
Method of measurement
Immunoassay
Secondary outcomes
1
Description
stent thrombosis
Timepoint
30 days after PCI
Method of measurement
Observation, ECG, Echocardiography
Intervention groups
1
Description
Intervention group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with 1000 mg per day Oral administration of Curcumin that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography (1000mg- 3 days before PCI)
Category
Prevention
2
Description
Control group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with Oral administration of Placebo that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Research Hospital
Full name of responsible person
Kaveh OraiiYazdani
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3341 2040
Email
dr.k.o.yazdani@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Kaveh OraiiYazdani
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3341 2040
Email
dr.k.o.yazdani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Kaveh OraiiYazdani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3341 2040
Email
dr.k.o.yazdani@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Kaveh OraiiYazdani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3341 2040
Email
dr.k.o.yazdani@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Samira Shahraki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Department of Physiology, School of Medicine, Zahedan University of Medical Sciences, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 2040
Email
shahrakis@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD