Effectiveness of Intravenous and intracoronary Vitamin C for the Prevention of Periprocedural Myocardial Injury And Contrast‐Induced Acute Kidney Injury in Patients Undergoing Primary Percutaneous Coronary Intervention.
This interventional study will be conducted as a prospective, Single-center, randomized trial. 110 patients with Acute STEMI admitted to Tehran Heart Center since the April 2016 and scheduled for Primary PCI will be selected. All patients who meet the eligibility criteria with informed consent will be randomized in a 1:1 ratio to receive during surgical procedure an intravenous and intracoronary of Vitamin C or Placebo. In a group before angioplasty and stenting, three grams of vitamin C as a bolus intravenously in the emergency department and 96 mg of vitamin C intracoronary in cathlab after stenting in addition to other routine treatments will be administered and other groups will receive other routine treatments only. Blood samples will be collected in the study patients before and 6 and 18 hours after PCI to measure CK-MB and Troponin I and two groups will compared. On the blood samples taken from these two groups for zero-hour clock and 6 clocks NGAl kit will be tested for prediction of contrast induced acute kidney injury.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706168698N21
Registration date:2017-08-20, 1396/05/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Intravenous and intracoronary Vitamin C for the Prevention of Periprocedural Myocardial Injury And Contrast‐Induced Acute Kidney Injury in Patients Undergoing Primary Percutaneous Coronary Intervention.
Public title
Vitamin C and Percutaneous Coronary Intervention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Subjects (men or women) at least 18 years and less than 80 years of age; Ischemic discomfort ≥ 20 min and < 6 hours of duration; ST elevation ≥ 1 mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2mm (≥0.2mV) in two contiguous precordial leads ; Planned primary PCI within 2 hours of hospital presentation; Planned or concomitant use of aspirin,
clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery; Informed consent able to be obtaine
Exclusion Criteria: Age ≥80 years;
Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation; Current warfarin therapy; Known allergy or contraindication to fibrinolvtics OR aspirin OR heparin OR clopidogrel; Patients with evidence of coronary collaterals (2-3 Rentrop) to the region at risk on previous coronary angiography (at the previous admission);Renal failure(creatinine>4.0 mg/dl).
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Ethics committee of Tehran University of Medical Sciences
Street address
No. 23, before Pour Sina St. - 16th Azar St. - Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.TUMS.PSRC.REC.1396.2529
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site Transmural myocardial infarction NOS
Primary outcomes
1
Description
myocardial infarction
Timepoint
before intervention
Method of measurement
clinical history and ECG
2
Description
Troponin I
Timepoint
before and 6, 18 hour after PCI
Method of measurement
ELISA
3
Description
Creatine Kinase-MB
Timepoint
before and 6,18 hour after PCI
Method of measurement
spectrophotometry
4
Description
NGAL
Timepoint
before and 6 hour after PCI
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Moreover the routine treatment before primary PCI and stenting of
culprit lesion 3 gram of intravenus vitamin C bolus and after stenting 96 mg intracoronary will be inject.
Category
Treatment - Drugs
2
Description
Control group: routine treatment will be do.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
6th floor; Corner of Quds Street; Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research,Tehran University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Azita Haj Hossein Talasaz
Position
PharmD, BCPS, AQ-Card
Other areas of specialty/work
Street address
Tehran Heart Center;North Kargar st.; Corner of Jalal Al Ahmad Highway.
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
atalasaz@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Resident in Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy; Tehran University; Pour Sina St.
City
Tehran
Postal code
Phone
+98 21 64120
Fax
Email
negar.shafaei89@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Shafaei Bajestani
Position
Resident in Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy; Tehran University; Pour Sina St
City
Tehran
Postal code
Phone
+98 21 64120
Fax
Email
negar.shafaei89@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)