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Study of the safety and clinical outcomes of fasting comparing to non-fasting before elective coronary angiography: A randomized clinical trial

Protocol summary

Study aim
Reducing the complications caused by fasting and presenting the non-fasting protocol to doctors in order to perform the angiography procedure as best as possible.
Design
Clinical trial with a control group, randomized, on 292 patients. The stratified block randomization method will be used for randomization.
Settings and conduct
This randomized clinical trial will be performed in Dr. Heshmat Heart Hospital in Rasht during 2023-2024. Participants will be randomly divided into fasting and non-fasting groups. Demographic information of the patients including age, sex, body mass index, condition of underlying diseases, the use of oral hypoglycemic drugs or injectable insulin, the history of hypoglycemia, the rate of pulmonary aspiration during the procedure, the rate of hypoglycemia in the duration of fasting, gastrointestinal symptoms, vasovagal occurrence during the procedure and when the sheet is removed, the prevalence of hypotension, as well as the patient's satisfaction with the entire procedure will be collected and recorded. All these outcomes will be evaluated during and immediately after the completion of coronary angiography.
Participants/Inclusion and exclusion criteria
All patients who are candidates for elective angiography will be entered to the study. If the patient undergoes emergency, complicated, incomplete or unsuccessful angiography, has recently experienced symptoms of dizziness and convulsions, or is pregnant, or has swallowing disorders, feeding with digestive tubes, will be excluded.
Intervention groups
In the intervention group 146 candidates for elective coronary angiography will not fast before it and are allowed to consume food and liquids in any amount.
Main outcome variables
Occurrence of pulmonary aspiration during the procedure, occurrence of hypoglycemia during fasting and blood pressure reduction, occurrence of vasovagal during sheet removal.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220809055645N3
Registration date: 2023-05-20, 1402/02/30
Registration timing: prospective

Last update: 2023-05-20, 1402/02/30
Update count: 0
Registration date
2023-05-20, 1402/02/30
Registrant information
Name
Fatemeh Baharvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
dr.baharcardio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the safety and clinical outcomes of fasting comparing to non-fasting before elective coronary angiography: A randomized clinical trial
Public title
Study of the safety and clinical outcomes of fasting comparing to non-fasting before elective coronary angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years of age who are candidates for elective angiography at Dr. Heshmat Hospital in Rasht during the period of 2022-2023
Exclusion criteria:
Emergency, complicated, incomplete or unsuccessful angiography Patients with swallowing disorders, feeding with digestive tubes Patients with symptoms of dizziness and seizures Pregnant
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 292
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling and randomization of this clinical trial study will be stratified blocked randomization method. In this way, each person was randomly assigned to the intervention or control group using 4 random blocks in a ratio of 1:1. In this method, one of the letters A or B will be assigned to each group.
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
Ethics Committee of Guilan University of Medical Sciences
Street address
Cardiovascular Disease Research Center, Dr Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
City
rasht
Province
Guilan
Postal code
4193955588
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.GUMS.REC.1402.032

Health conditions studied

1

Description of health condition studied
Ischemic heart disease
ICD-10 code
ICD-10 code description
coronar

Primary outcomes

1

Description
Occurrence of pulmonary aspiration during the procedure, occurrence of hypoglycemia during fasting and blood pressure drop, occurrence of vasovagal during sheet removal.
Timepoint
The time period for measuring these results is until the sheet is removed, which will be 3 hours after the procedure for angiography and 4 hours after the procedure for angioplasty.
Method of measurement
The method of measurement for the studied samples will be the researcher-made checklist .

Secondary outcomes

1

Description
Gastrointestinal symptoms and patient satisfaction with the procedure
Timepoint
The time period for measuring these results is until the sheet is removed, which will be 3 hours after the procedure for angiography and 4 hours after the procedure for angioplasty.
Method of measurement
The method of measurement for the studied samples will be the researcher-made checklist.

Intervention groups

1

Description
Intervention group: The intervention group will include 146 candidates for elective coronary angiography, who will enter the study with personal consent and after completing the informed consent form. The participants in this group will not fast before the angiography and are allowed to consume food and liquids in any amount. All patients over 18 years of age who are candidates for elective angiography in Dr. Heshmat Rasht Hospital during the period of 2014-2014 will be included in the study. If the patient undergoes emergency, complicated, incomplete or unsuccessful angiography, or if they have swallowing disorders, feeding with digestive tubes, they will be excluded from the study. In addition, if the patient has symptoms of dizziness and convulsions recently or is pregnant, she will be excluded from the study.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Heshmat Heart Hospital
Full name of responsible person
Fatemeh Baharvand
Street address
Cardiovascular Disease Research Center,Dr Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square,, Guilan,Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3366 8718
Email
dr.baharcardio@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Cardiovascular Diseases Research Center, Dr. Heshmat Rasht Hospital, 5th of Khordad Streat, Mosalla Square, Guilan, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3366 8718
Email
dr.baharcardio@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Baharvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3366 8718
Email
dr.baharcardio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Baharvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3366 8718
Email
dr.baharcardio@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Baharvand
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Cardiovascular Diseases Research Center, Dr. Heshmat Heart Hospital, 15th of Khordad Street, Mosalla Square, Guilan, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
+98 13 3366 8718
Email
dr.baharcardio@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patients' information will be kept confidential and it will be only available to this project's researchers.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Parts of the data, such as information related to the main outcomes can be shared
When the data will become available and for how long
"Starting the access period 2 years after the results are published"
To whom data/document is available
Researchers of the study
Under which criteria data/document could be used
Journal if needed
From where data/document is obtainable
Fatemeh Baharvand
What processes are involved for a request to access data/document
Request for data should be sent via email to Dr. Fatemeh Baharvand. dr.baharcardio@gmail.com
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