Protocol summary

Summary
Aim: Coronary angiography involves the selective injection of a radiographic contrast agent in the coronary arteries. Intravenous heparin may be given at the time of catheter insertion in some center. But optimal strategy for administering heparin to patients undergoing coronary angiography remains unclear. The aim of this study is evaluation of heparin administration effects during diagnostic coronary angiography in Ekbatan hospital centre. Materials and Methods: This was a randomized controlled clinical trial study which was done on 500 patients, undergoing diagnostic coronary angiography via femoral approach. Patients initially were divided to two groups, 250 cases were on intravenous (heparin) and 250 on no heparin. We studied during and post angiographic vascular complications (active bleeding, groin hematoma, retroperitoneal hematoma, pseudoaneurysm, Ischemic cerebral and peripheral vascular accident and clot during angiography). The data such as age ,sex, ejection fraction, positive history of hypertension, diabetes mellitus, severe peripheral vascular disease, aortic stenosis and coagulopathy were collected via questionnaires. All patients with CAD referred to Ekbatan hospital for coronary angiography. Patients with severe AS, PVD , coagulopathy and angiography procedures more than 30 minutes were excluded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202199080N1
Registration date: 2012-03-15, 1390/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Mohsen Gharakhani
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 0947
Email address
gharakhani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2006-09-21, 1385/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of heparin administration effects during diagnostic coronary angiography in coronary artery disease for active bleeding, hematoma, pseudoanuerysm and ischemic accidents
Public title
Heparin administration in coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients with CAD referred to Ekbatan hospital for coronary angiography. Exclusion criteria: patients with severe AS, PVD, coagulopathy and angiography procedures more than 30 minutes.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 500
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
Hamadan university of medical sciences
Street address
Hamadan university of medical sciences
City
Hamadan
Postal code
Approval date
2012-02-16, 1390/11/27
Ethics committee reference number
4226/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Hematoma, active bleeding
Timepoint
until 30 days after angiography
Method of measurement
inspection and clinical evaluation

Secondary outcomes

1

Description
Cerebrovascualr accident
Timepoint
until 30 days after angiography
Method of measurement
inspection and clinical evaluation

Intervention groups

1

Description
heparin administration during coronary angiography in Atherosclerotic heart disease (3000 unit/IV)
Category
Treatment - Drugs

2

Description
No administration of Heparin in control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Mosen GHarakhani
Street address
Cardiovascular ward, Ekbatan Hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Abbas Zamanian
Street address
Hamadan Univresity of Meical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Mohsen GHarakhani
Position
Academic Member, Assistant Professor
Other areas of specialty/work
Street address
Cardiovascular ward, Ekbatan Hospital
City
Hamadan
Postal code
Phone
+98 81 1825 1245
Fax
Email
gharakhani@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohsen GHarakhani
Position
Cardiologist
Other areas of specialty/work
Street address
Cardiovasular Ward, Ekbatan Hospital
City
Hamadan
Postal code
Phone
+98 81 1825 1245
Fax
Email
gharakhani@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of medical sciences
Full name of responsible person
Mohsen Gharakhani
Position
academic member assistant professor
Other areas of specialty/work
Street address
Cardiovascular ward, Ekbatan Hospital
City
Hamadan
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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