Prospective evaluation of the effect of statin recapture on high sensitive troponin T and NGAL in elective PCI patients referred to Tehran Heart Center
Objective: To determine the effect of statin recapture on high sensitive troponin T and NGAL in elective PCI patients referred to Tehran Heart Center
Study design: Randomized, not blinded, no use of placebo, unicenter, phase IV trial
Population:
Inclusion criteria: candidate for Elective Percutaneous Coronary Intervention
Exclusion criteria: High-Sensitivity Cardiac Troponin more than 24 NG/ML; Creatinine Clearance less than 30; Liver function test more than 3 times greater than normal; Ejection fraction less than 30 percent; Consumption of Amiodarone, Calcium channel blockers, Colchicine, and Digoxin
Target sample size: 340 patients
Intervention:
- Atorvastatin, two 40 mg pills, 12 hours before PCI
- Atorvastatin, 40 mg pill, 2 hours before PCI
Primary outcome measures:
-Serum high sensitive troponin T is measured by ELISA before and within 24 hours after PCI.
- Urine NGAL is measured by ELISA before and 2 hours after PCI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011831073N2
Registration date:2017-05-02, 1396/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-02, 1396/02/12
Registrant information
Name
Hamidreza Poorhoseini
Name of organization / entity
Tehran University of Medical Sciences,Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9721
Email address
porhosei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences/ Tehran Heart Center
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prospective evaluation of the effect of statin recapture on high sensitive troponin T and NGAL in elective PCI patients referred to Tehran Heart Center
Public title
Evaluation of the effect of very high dose atorvastatin on candidates for elective angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for Elective Percutaneous Coronary Intervention
Exclusion criteria: High-Sensitivity Cardiac Troponin more than 24 NG/ML; Creatinine Clearance less than 30; Liver function test more than 3 times greater than normal; Ejection fraction less than 30 percent; Consumption of Amiodarone, Calcium channel blockers, Colchicine, and Digoxin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Randomized
Randomization description
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
16 Azar St, Enghelab Sq, Tehran Province
City
Tehran
Postal code
1417614418
Approval date
2017-03-01, 1395/12/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1845
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction after elective stenting, contrast-induced nephropathy after elective stenting
ICD-10 code
I25.1, I25
ICD-10 code description
Atherosclerotic heart disease, Old myocardial infarction
Primary outcomes
1
Description
Serum high sensitive troponin T
Timepoint
Before and within 24 hours after PCI
Method of measurement
ELISA
2
Description
Urine NGAL
Timepoint
Before and 2 hours after PCI
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Atorvastatin, two 40 mg pills, 12 hours before PCI and 40 mg atorvastatin 2 hours befor PCI
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr.Reza Lashkari
Street address
North Kargar Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Room 302, first floor, Medical office building (number one), School of Medicine, Tehran University of Medical Sciences, Ebnesina street, 16 Azar street, Enghelab avenue, Enghelab square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr.Hamidreza Poorhosseini
Street address
Tehran Heart Center,North Kargar Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?