The Effect of preprocedural and intraprocedural Vitamin C Infusion on decrease Thrombolysis in myocardial infarction(TIMI) flow grade and Myocardial Perfusion Grade (MPG) for Patient Undergoing Primary Percutaneous coronary intervention( PCI)
This interventional study of elective clinical trial to study effect of Vitamin C on Coronary Reperfusion Indexes will be conducted in which 320 patients since the spring of 2016 on wards diagnosed with Acute STEMI for Primary PCI to catheterization ward of Tehran Heart Center introduced as a standard inclusion and exclusion criteria , with informed consent and the study will be selected. Patients on the basis of criteria defined quite similar in the two groups of 160 patients randomly divided and in a group before angioplasty and stenting, three grams of a bolus of vitamin c intravenously in the emergency department and 96 mg of the intracoronary also in cathlab after stenting in addition to other routine treatments will be administered through angioplasty and stenting and other groups will perform other routine treatments only . After angioplasty with re-injection of contrast agent, the flow grade (Thrombolysis In Myocardial Infarction (TIMI) and (MPG) Myocardial Perfusion Grade aimed at two groups will compare.on the blood samples taken from these two group for zero-hour clock and 6 clock the P-selectin kit will be tested for platelet aggregation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606048698N19
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
The Effect of preprocedural and intraprocedural Vitamin C Infusion on decrease Thrombolysis in myocardial infarction(TIMI) flow grade and Myocardial Perfusion Grade (MPG) for Patient Undergoing Primary Percutaneous coronary intervention( PCI)
Public title
The effect of vitamin C on acute MI in primary PCI setting
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
Subjects (men or women) at least 18 years and less than 80 years of age; Ischemic discomfort ≥20 minutes and ≤6 hours of duration;
ST elevation ≥1mm (≥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 fibrinolytics 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) .
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:
320
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
Ethic committee of Tehran University of Medical Science
Street address
building (1),Poursina Avenue, Qods Street, Enqelab Square.
City
Tehran
Postal code
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1016
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
Primary outcomes
1
Description
myocardial infarction
Timepoint
before intervention
Method of measurement
clinical history and ECG
2
Description
myocardial perfusion grade
Timepoint
after PCI
Method of measurement
by angiographic interpretation
3
Description
TIMI flow
Timepoint
after stenting
Method of measurement
by angiographic interpretation
4
Description
p selectin kit
Timepoint
one month
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Interventional group: moreover the routin treatment, before primary PCI and stenting of culprit lesion 3 gram of intravenus vitamin C bolusand after stenting 96 mg again will be inject.
Category
Treatment - Drugs
2
Description
Control group: routine treatement
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Seyed Farshad Sadri Jokandan
Street address
North KargarAve , Tehran,Iran
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
Keshavarz blvd, Quds St, Tehran Province
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 University of Medical Sciences
Full name of responsible person
Haj HoseinTalasaz Azita
Position
PharmD, BCPS, AQ-Card
Other areas of specialty/work
Street address
Keshavarz blvd, Quds St,Poursina St, Tehran
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 Heart Center
Full name of responsible person
Seyyed Farshad Sadri Jokandan
Position
Resident
Other areas of specialty/work
Street address
North Kargar-Ave , Tehran-Iran
City
Tehran
Postal code
Phone
+98 21 8802 9600
Fax
Email
farshadsadr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Seyyed Farshad Sadri Jokandan
Position
Resident
Other areas of specialty/work
Street address
North Kargar-Ave , Tehran-Iran
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
Farshadsadr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)