- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05581368
Studying the Effects of Cannabis on Vasculature (SECV)
Elucidating the Effects of Cannabis on Cardiovascular System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mark Chandy, MD, PhD
- Phone Number: 5196612111
- Email: mark.chandy@lhsc.on.ca
Study Contact Backup
- Name: Kerry-Ann Nakreiko, PhD
- Phone Number: 80249 5196612111
- Email: Kerry-Ann.Nakrieko@lhsc.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- Recruiting
- London Regional Health Science Centre
-
Contact:
- Mark Chandy, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age: 19 to 80
- males and females
- all ethnicities
- cannabis use at least 3-4 times per week or more in the past 6 months (50 volunteers, experimental group)
- patients who do not use cannabis (50 volunteers, control group)
- no history of cardiovascular disease
Exclusion Criteria:
- that ingest cannabis containing cannabidiol (CBD)
- that are unable to provide a receipt for the cannabis product(s) they ingest
- that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chronic Cannabis Cohort
For investigations on the effects of cannabis on the cardiovascular system, the investigators would like to recruit 50 participants with the following inclusion criteria:
For investigations on the effects of cannabis on the cardiovascular system, the investigators will exclude cannabis users:
|
The investigators will test levels of inflammation and vascular dysfunction in participants who chronically use cannabis.
|
|
Control Cohort
For investigations on the effects of cannabis on the cardiovascular system, the investigators would like to recruit 50 participants with the following inclusion criteria:
For investigations on the effects of cannabis on the cardiovascular system, the investigators will exclude participants:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammation
Time Frame: Baseline measurement.
|
The investigators will measure the concentration of inflammatory cytokines using an Olink for chronic cannabis users and the control group.
|
Baseline measurement.
|
|
Endothelial function
Time Frame: Baseline measurement.
|
The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups.
|
Baseline measurement.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cholesterol Level
Time Frame: Baseline measurement.
|
The investigators will measure lipid profile (total cholesterol, LDL, HDL, ratio) for both groups.
|
Baseline measurement.
|
|
BMI
Time Frame: Baseline measurement.
|
The investigators will measure body-mass index or both groups.
|
Baseline measurement.
|
|
Blood pressure
Time Frame: Baseline measurement.
|
The investigators will measure baseline blood pressure for both groups.
|
Baseline measurement.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCVP0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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