Effect of preparation trough non-regional induced ischemia in the prevention of contrast medium nephropathy in patients undergoing coronary angiography or angioplasty
Objective: Effect of preparation trough non-regional induced ischemia in the prevention of contrast medium nephropathy in patients undergoing coronary angiography or angioplasty. Design: Interventional, Non-blinded, Randomized Sample size: 51 People. Inclusion criteria: The patients undergoing angiography or angioplasty due to elevated acute coronary syndrome (Non-ST Elevation Myocardial Infarction); Patients who have risk score more than 6, based on Mehran studies. Exclusion criteria: Patients undergoing ST Elevation Myocardial Infarction; Patients undergoing cardiogenic shock; Patients with severe heart failure (NYHA class 3 or 4, or left ventricular ejection fraction less than 30%) that do not tolerate mentioned protocol of treatment fluid; Kidney transplant patients or patients undergoing dialysis; Patients who receive contrast coroner substance a week before angiography or angioplasty; Patients who can not stand cuff inflation for 5 minutes. Intervention group: Angiogram or angioplasty patients after angiography or angioplasty receive induction of ischemic limbs in 4 times. Control group: Patients who receive Normal Saline in 1.5 CC for a kilogram in an hour, during 3 to 12 hours before and 6 to 24 hours after angiography or angioplasty. Primary outcome measure: Failure caused by Contrast medium, 24 to 48 hours after angiography or angioplasty is checked via blood test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061422713N1
Registration date:2015-06-30, 1394/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-30, 1394/04/09
Registrant information
Name
Masoud Sajadi
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0000
Email address
sajjadim961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preparation trough non-regional induced ischemia in the prevention of contrast medium nephropathy in patients undergoing coronary angiography or angioplasty
Public title
Prevention of contrast nephropathy in patients undergoing coronary angiography or angioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients undergoing angiography or angioplasty due to elevated acute coronary syndrome (Non-ST Elevation Myocardial Infarction); Patients who have risk score more than 6, based on Mehran studies.
Exclusion criteria: Patients undergoing ST Elevation Myocardial Infarction; Patients undergoing cardiogenic shock; Patients with severe heart failure (NYHA class 3 or 4, or left ventricular ejection fraction less than 30%) that do not tolerate mentioned protocol of treatment fluid; Kidney transplant patients or patients undergoing dialysis; Patients who receive contrast cronary substance a week before angiography or angioplasty; Patients who can not stand cuff inflation for 5 minutes; Patients with bleeding disorders so that they suffered at least 1 gram per deciliter Hb falling.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
51
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
Vice Chancellor for Research, Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah St, Mashhad
City
Mashhad
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
920581
Health conditions studied
1
Description of health condition studied
Contrast medium Nephropathy
ICD-10 code
N14.2
ICD-10 code description
Nephropathy induced by unspecified drug, medicament or biological substance
Primary outcomes
1
Description
Failure caused by Contrast medium (CIN)
Timepoint
24 to 48 hours after angiography or angioplasty
Method of measurement
Blood test
2
Description
Blood creatinine level
Timepoint
24 to 48 hours after angiography or angioplasty
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Angiogram or angioplasty patients who after angiography or angioplasty in 4 times receive induction of ischemic limbs after angiography or angioplasty in 4 times.
Category
Prevention
2
Description
Control group: Patients who received Normal Saline in 1.5 CC for a kilogram in an hour, during 3 to 12 hours before and 6 to 24 hours after angiography or angioplasty.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Masoud Sajadi
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah St, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Imam Reza Hospital
Full name of responsible person
Seyed Mesoud Sajadi
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3841 4499
Fax
Email
s.masoud.sajjadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Seyed Mesoud Sajadi
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3841 4499
Fax
Email
s.masoud.sajjadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Seyed Mesoud Sajadi
Position
Resident
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3841 4499
Fax
Email
s.masoud.sajjadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)