Comparison of coronary angiography and percutaneous coronary intervention via left distal radial artery versus femoral artery in post coronary artery bypass grafting patients; A pilot study
Comparison of angiography and coronary interventions through left distal radial artery and femoral artery in patients with history of coronary artery bypass graft surgery
Design
1:1 randomized unblinded clinical trial, with parallel groups, on 60 patients (30 in each group) using table of random numbers.
Settings and conduct
This prospective clinical trial will be performed at Tehran Heart Center in 2020. For this purpose, all patients with a history of coronary artery bypass grafting who are referred to this center for cardiac catheterization will be evaluated. Patients are 1:1 randomly divided into two groups of radial and femoral access which is based on random numbers given by the computer. The procedures will be performed by the Interventional Cardiology Fellowship. Finally, A questionnaire will be filled for each patient and the data will be analyzed by SPSS software version 25 .
Participants/Inclusion and exclusion criteria
inclusion criteria:
Age between 18 and 90 years,
History of coronary artery bypass graft surgery,
Clinical indication for angiography and or angioplasty,
No contraindication for contrast agents
Able to provide informed consent
Normal Allen test
Exclusion criteria:
Vascular disorder that makes it difficult to access the femoral or radial arteries
Intervention groups
In the first intervention group, coronary angiography or angioplasty is performed through catheterization of the femoral artery and in the second intervention group, coronary angiography or angioplasty is performed through radial artery catheterization.
Main outcome variables
Contrast volume; Fluoroscopic time; Vascular complications after the procedure at the site of the sheath implantation; Total procedure time; amount of radiation received, amount of heparin; vascular spasm in radial method; Number of wire and catheter used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200712048083N1
Registration date:2022-02-05, 1400/11/16
Registration timing:retrospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Lale Farzadi niaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 6375
Email address
lale_farzadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of coronary angiography and percutaneous coronary intervention via left distal radial artery versus femoral artery in post coronary artery bypass grafting patients; A pilot study
Public title
Coronary angiography via left distal radial artery vs femoral artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 90 years
History of coronary artery bypass graft surgery
clinical indication for coronary and graft angiography and/or intervention
No contraindication for contrast agents
Able to provide informed consent
Normal Allen test
Exclusion criteria:
Vascular disorder that makes it difficult to access the femoral or radial arteries
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into into two groups of radial and femoral access by 1:1 simple individual randomization method based on a table of random numbers created by a computer to carry out allocation concealment.
Randomization was performed using "www.random.org" list generator.
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
Cardiovascular Ethics Committee of Tehran Heart Center
Street address
Tehran Heart Center , north karegar st,Tehran Town
City
tehran
Province
Tehran
Postal code
١٣١٣٨١٤١١٧
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.TUMS.THC.REC.1399.006
Health conditions studied
1
Description of health condition studied
Angiography/angioplasty of coronary arteries
ICD-10 code
Z98.61
ICD-10 code description
Coronary angioplasty status
Primary outcomes
1
Description
Contrast volume
Timepoint
During procedure
Method of measurement
Using the container in the angiography room, the amount of Contrast volume consumption is calculated from the beginning to the end of the procedure.
2
Description
Fluoroscopic time
Timepoint
During procedure
Method of measurement
Using the calculations of the device used in the angiography room - Artis zee-siemens - Philips Aluuura FD10 & FD20
3
Description
Vascular complications after the procedure at the site of sheath implantation
Timepoint
During the procedure, after the procedure, and at the time of discharge
Method of measurement
Based on examination and use of Reverse barbeau test
4
Description
Total procedure time
Timepoint
During procedure
Method of measurement
From the time of lidocaine injection until the end of the procedure is recorded by the operator.
5
Description
Amount of radiation received
Timepoint
During procedure
Method of measurement
Based on the calculation of the angiography device (DAD and A.K)
6
Description
Amount of Heparin
Timepoint
During procedure
Method of measurement
Based on the amount of heparin unit injected into the patient during the procedure, which is recorded by the operator.
7
Description
Vascular spasm in radial method
Timepoint
During procedure
Method of measurement
Radial Spasm Grading due to physical exam then Matching with the corresponding algorithm
8
Description
Number of wire and catheters used
Timepoint
During procedure
Method of measurement
Number of wires and catheters consumed during the procedure recorded by the operator.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients undergo angiography or angioplasty through the left distal radial artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this group, patients undergo angiography or angioplasty through the femoral artery and the two groups are compared in terms of contrast volume, fluoroscopic time, vascular complications after the procedure at the site of sheath implantation, total procedure time, amount of radiation received, amount of heparin, vascular spasm in radial method, number of wire and catheter used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Yaser Jenab
Street address
Tehran Heart Center,North kargar st
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9600
Email
yasjenab@gmail.com
Web page address
http://thc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr saeid sadeghian
Street address
Tehran Heart Center, North kargar St
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9600
Email
ssadeghian@tums.ac.ir
Web page address
http://thc.tums.ac.ir/
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
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
Tehran University of Medical Sciences
Full name of responsible person
Lale Farzadi Niaki
Position
Cardiac Intervention Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar St
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
009888029600
Email
lale_farzadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lale Farzadi Niaki
Position
Cardiac Interventional Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
009888029600
Email
lale_farzadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lale Farzadi Niaki
Position
Interventional cardiology fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
009888029600
Fax
Email
lale_farzadi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available