Evaluating the effect of lycopene on cardic biomarkers, Inflammatory factors and Matrix metalloproteinase 9 in patients undering elective Percutaneous Coronary Intervention
Investigation of the effects of lycopene on serum levels of cardiac biomarkers of myocardial ischemia and high-sensitivity C-reactive protein (hs-CRP) in patients undergoing elective coronary intervention (PCI)
Design
Two arm parallel group randomized controlled clinical trial
Settings and conduct
Chamran Hospital, Cardiovascular Research Center
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Over 40 years old
2. Use of aspirin 80 to 100 mg daily for at least 5 days before PCI
3. Completion of informed consent
4. Being a candidate for elective PCI
5. No use of other antioxidants including vitamins C and E, coenzyme Q10, selenium, anthocyanin supplements and lycopene supplements 1 week before study
6. No use of fish oil and omega-3 from 1 week before the study
Exclusion criteria:
1. Uncontrolled hypertension
2. Thrombocytopenia
3. Renal dysfunction (creatinine clearance less than 30 ml / min).
4. Hepatic dysfunction (liver enzymes more than three times the upper limit of normal)
5. Active bleeding
6. Pregnancy
7. Allergy to lycopene
Intervention groups
Control group: PCI with standard treatment (aspirin, statin, and beta-blocker)
Experimental group: PCI with standard treatment (aspirin, statin, and beta-blocker) with lycopene 30 mg 12 hours before PCI and 15 mg just after and 8 hours after PCI
Main outcome variables
Serum levels of Troponin I, CK-MB, hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191018045149N1
Registration date:2020-04-07, 1399/01/19
Registration timing:retrospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Sedigheh Asgary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3611 5310
Email address
sedighehasgary@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
2017-12-21, 1396/09/30
Actual recruitment end date
2018-08-22, 1397/05/31
Trial completion date
2018-08-22, 1397/05/31
Scientific title
Evaluating the effect of lycopene on cardic biomarkers, Inflammatory factors and Matrix metalloproteinase 9 in patients undering elective Percutaneous Coronary Intervention
Public title
The effect of lycopene on serum level of cardiac biomarkers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient undergoing elective PCI surgery over 40 years old.
Consumption of 80 to 100 mg aspirin daily for at least 5 days before PCI
Completion of informed consent
No Consumption of other antioxidants including vitamins C and E, coenzyme Q10, selenium, anthocyanin supplements and lycopene supplements 1 week before study
No use of fish oil and omega-3 by 1 week before study
Exclusion criteria:
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was used for patients' allocation to the groups. For this, an online random number generator was used (available at: https://www.random.org/sequences) so that even and odd numbers were considered for drug and control groups, respectively.
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 Isfahan University of Medical Sciences
Serum levels of CK-MB, Troponin I and hs-CRP were measured in patients
Timepoint
Blood samples from both groups 12 hours before the intervention, 8 and 12 hours one and six months after the intervention
Method of measurement
5 ml blood was taken from the patient to measure serum CK-MB, Troponin I and hs-CRP levels.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: PCI with standard treatment (aspirin, statin, and beta-blocker)
Category
Treatment - Devices
2
Description
Experimental group: PCI with standard treatment (aspirin, statin, and beta-blocker) with lycopene 30 mg 12 hours before PCI and 15 mg just after and 8 hours after PCI
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital, Cardiovascular Research Center
Full name of responsible person
Dr. Rasoul Soltani
Street address
Hezar girib street
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Rasoul Soltani
Street address
Hezar jirib street
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7067
Email
soltani@pharm.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
Dr. Rasoul Soltani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jirib
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Rasoul Soltani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jirib street
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Rasoul Soltani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar jirib street
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.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