Protocol summary
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Study aim
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Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention(PCI) in patients with unstable angina(UA) in reducing Major adverse cardiovascular events(MACE)
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Design
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In this Single Blind Trial, 76 patients with serum vitamin D deficiency who are candidates for percutaneous coronary intervention(PCI) are randomly divided into two parallel groups.
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Settings and conduct
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In patients with unstable angina(UA) who are candidates for percutaneous coronary intervention(PCI) and are admitted to Ayatollah Mousavi Hospital during 2021, a venous blood sample will be taken before PCI to measure vitamin D levels. Patients with serum vitamin D deficiency(Less than 30ng/ml) underwent telephone and in-person follow-up in the form of history, physical examination, ECG and echocardiography during 3 and 6 months after PCI, and in terms of the occurrence of Major adverse cardiovascular events(MACE) including myocardial infarction, re hospitalization, need for revascularization in re hospitalization and mortality are monitored. finally, the frequency of MACE and its components are compared between the two groups.
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Participants/Inclusion and exclusion criteria
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Patients over 18 years of age with unstable angina and candidates for percutaneous coronary intervention(PCI) with serum vitamin D deficiency will be deliberately admitted to the study.
Patients with a history of myocardial infarction, revascularization or CABG will be excluded from the study.
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Intervention groups
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Patients were randomly divided into two groups before the intervention, so that the first group, in addition to routine drugs, treated with vitamin D (300,000 units orally 12 hours before PCI), and the second group will receive only routine medications.
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Main outcome variables
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Myocardial infarction; re hospitalization; need for revascularization in re hospitalization; mortality
General information
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Reason for update
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Edited by the Hospital Research Committee
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210228050528N1
Registration date:
2021-10-22, 1400/07/30
Registration timing:
prospective
Last update:
2022-10-29, 1401/08/07
Update count:
1
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Registration date
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2021-10-22, 1400/07/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-03-20, 1400/12/29
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Actual recruitment start date
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2021-10-24, 1400/08/02
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Actual recruitment end date
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2022-04-19, 1401/01/30
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Trial completion date
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2022-10-22, 1401/07/30
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Scientific title
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Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with unstable angina in reducing Major adverse cardiovascular events
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Public title
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Evaluation of the effect of vitamin D before percutaneous coronary intervention in the prevention of cardiovascular complications
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with unstable angina who are candidates for PCI
Patients with deficient serum levels of vitamin D
Exclusion criteria:
Previous history of myocardial infarction
Previous history of revascularization therapy interventions
Patients with a previous history of CABG
Patients with failed PCI
Simultaneous involvement of valvular disorders
Take vitamin D, calcium or omega-3 supplements in the last 3 months
Patients with hypercalcemia, nephrolithiasis, sarcoidosis, malabsorption syndromes
Chronic underlying diseases such as liver, kidney or rheumatic disorders
Pregnancy and lactation
Having malignancies
History of receiving corticosteroids or immunosuppressants in the last 6 months
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
76
Actual sample size reached:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, patients are divided into simple randomizations using randomly generated computer-generated numbers by an independent individual.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, patients will be unaware of the nature of the prescribed drug, that is, after randomly dividing patients into two groups, the first group in addition to routine pre-intervention drugs, treated with vitamin D (three hundred thousand units orally 12 Hours before the intervention), and the second group will receive only routine pre-intervention medications.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-01, 1400/06/10
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Ethics committee reference number
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IR.ZUMS.REC.1400.218
Health conditions studied
1
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Description of health condition studied
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Major adverse cardiovascular events
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ICD-10 code
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R94.30
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ICD-10 code description
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Abnormal result of cardiovascular function study, unspecified
2
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Description of health condition studied
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Precutaneous coronary intervention
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ICD-10 code
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Z95.5
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ICD-10 code description
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Presence of coronary angioplasty implant and graft
3
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Description of health condition studied
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Unstable angina
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ICD-10 code
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I25.110
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
Primary outcomes
1
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Description
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Number of myocardial infarction cases
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Timepoint
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3 and 6 months later
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Method of measurement
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ECG and echocardiography
2
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Description
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Number of revascularization cases in re hospitalization
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Timepoint
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3 and 6 months later
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Method of measurement
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ECG and echocardiography
Secondary outcomes
1
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Description
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Readmission rate
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Timepoint
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3 and 6 months later
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Method of measurement
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ECG and echocardiography
2
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Description
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Mortality rate
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Timepoint
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3 and 6 months later
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Method of measurement
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In-person and telephone follow-up
3
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Description
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Cardiac function
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Timepoint
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3 and 6 months later
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Method of measurement
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In-person follow-up
Intervention groups
1
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Description
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Intervention group: A group that, in addition to routine pre-PCI medications, is treated with 300,000 units of oral vitamin D (six 50,000 units of vitamin D tablets produced by Zahravi Pharmaceutical Company) 12 hours before PCI.
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Category
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Treatment - Drugs
2
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Description
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Control group: The group that only receives routine medications before PCI.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Part of the data, such as information about the primary or secondary outcome, will be shared.
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Researchers in academic and scientific institutions
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Under which criteria data/document could be used
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The data and documents of the study will be available for the use of other researchers in academic and scientific institutions in relation to related topics with ethical principles.
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From where data/document is obtainable
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My e-mail address : Amirshahbazzadeh@yahoo.com
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What processes are involved for a request to access data/document
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The applicant can access the study data and documents after submitting the requirement on reputable sites and online correspondence with me.
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Comments
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