The aim of this single center phase 2 randomized controlled trial was to investigate the effects of nitroglycerine on the early complications of angiography in 123 candidates of coronary angiography. The patients were randomly assigned into intervention (111 patients) or placebo (112 patients) group to receive a mixture of dye and TNG or sterile water, respectively, for angiography. Nausea, coronary artery spasm, bradyarrhythmia, chest pain and systolic and diastolic blood pressure were measured during and after angiography and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901283733N1
Registration date:2010-06-12, 1389/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Masoumeh Sadeghi
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1335 9696
Email address
roohafza@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2005-05-10, 1384/02/20
Expected recruitment end date
2005-11-21, 1384/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nitroglycerine injection with placebo on angiographic complications in patients with suspected ischemic heart disease
Public title
The effect of Trinitroglycerine injection on angiographic complications
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent, age between 20 and 75 years, no drug addiction, lack of brain vascular disease and systolic blood pressure above 100 mmHg, candidates for angiography, hemodynamic stability,
Exclusion criteria: history of heart disease, history of hypertension
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
223
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Cardiovascular Research Center/Isfahan University of Medical Sciences
Street address
Isfahan Cardiovascular Research Center, khorram Ave., Isfahan.
City
Isfahan
Postal code
81465-1148
Approval date
2005-04-20, 1384/01/31
Ethics committee reference number
84621
Health conditions studied
1
Description of health condition studied
Diseases of the circulatory system
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea
Timepoint
during angiography
Method of measurement
patient observation and expression
2
Description
Coronary artery spasm
Timepoint
during angiography
Method of measurement
angiography film
3
Description
Chest pain
Timepoint
during angiography
Method of measurement
Pain by the patient during angiography is reported ECG changes in addition to rising or down piece ST
4
Description
systolic and diastolic blood pressure
Timepoint
during angiography
Method of measurement
monitoring intravascular pressure device that was attached to the patient during angiography
5
Description
Brady arrhythmia
Timepoint
during angiography
Method of measurement
ECG monitoring during angiography
Secondary outcomes
empty
Intervention groups
1
Description
Injection of 5 micrograms TNG in 150 cc Mglomyn dye. Time: During angiography.
Category
Prevention
2
Description
150 cc Myglomyn dye was mixed with 5 micrograms strile water and was injectrd during angiography.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran hospital of Isfahan
Full name of responsible person
Dr Ramin Heydari
Street address
Chamran hospital, Abshare sevom Ave., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Director of Finance, Faculty of Medicine
Street address
Isfahan University of Medical Sciences, Azadi Square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan Cardiovascular Research Center/Isfahan University of medical Science
Full name of responsible person
Dr Masoumeh Sadeghi
Position
Associate professor of cardiology
Other areas of specialty/work
Street address
Isfahan Cardiovascular Research Center, khorram Ave.
City
Isfahan
Postal code
81465-1148
Phone
+98 31 1335 9090
Fax
+98 31 1337 3435
Email
sadeghimasoumeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Cardiovascular Research Center
Full name of responsible person
Dr Masoumeh Sadeghi
Position
Associate professor of cardiology
Other areas of specialty/work
Street address
Isfahan Cardiovascular Research Center,Khoram Ave, Jomhory Square
City
Isfahan
Postal code
81465-1148
Phone
+98 31 1335 9090
Fax
+98 31 1337 3435
Email
sadeghimasoumeh@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)