The aim of the study is assessing the role of melatonin in preventing the blood pressure and heart rate rise during coronary angiography. The patients who are candidates of elective coronary angiography according to current guideline and are not admitted with acute coronary syndrome and do not have history of hypertension will be enrolled. 134 patients will be randomly received 5 mg melatonin pills or placebo for five days before angiography. The heart rate and blood pressure will be recorded before angiography and during procedure in all patients. The recordings of both groups will be compared and we will see if melatonin administration before angiography can prevent the tachycardia and hypertension that often were observed during angiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012105359N1
Registration date:2011-09-08, 1390/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-09-08, 1390/06/17
Registrant information
Name
Mohammad Alasti
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1445 7205
Email address
alastip@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Research Center of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-11-20, 1390/08/29
Expected recruitment end date
2012-11-20, 1391/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of melatonin on blood pressure and heart rate in patients undergoing elective coronary angiography?
Public title
Is melatonin useful in patients whom underwent coronary angiography.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients who are candidate of elective coronary angiography according to current guideline (ACC/AHA guideline 1999) who are admitted at Imam Khomeini Hospital from 20.11.2011 till 20.11.2012)
Exclusion criteria: history of hypertension; patients with acute coronary syndrome
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
ٍ96
Health conditions studied
1
Description of health condition studied
Chronic coronary disease
ICD-10 code
125.8
ICD-10 code description
Chronic ischaemic heart disese, nonsecified
Primary outcomes
1
Description
Heart rate, blood pressure
Timepoint
before and during angiography
Method of measurement
manometer
Secondary outcomes
1
Description
side effects of melatonin
Timepoint
before angiography
Method of measurement
filling the form
Intervention groups
1
Description
The cases will be received Melatonin or placebo for 5 days before angiography( one pill each night).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Mahdian Nasab
Street address
Azadegan avenue
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Alasti
Street address
Imam Khomeini Hospital
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
mohammad Mehdian nasab
Position
head nurse
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan avenue
City
Ahvaz
Postal code
Phone
+98 61 1222 6721
Fax
Email
alastip@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Mohammad Alasti
Position
assistant professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1222 6721
Fax
Email
alastip@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Alasti
Position
Assisstant professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan avenue
City
Ahvaz
Postal code
Phone
Fax
Email
alastip@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)