Canadian Study of Arterial Inflammation in Patients With Diabetes and Vascular Events: EvaluatioN… (NCT04181996) | Clinical Trial Compass
CompletedPhase 3
Canadian Study of Arterial Inflammation in Patients With Diabetes and Vascular Events: EvaluatioN of Colchicine
Canada115 participantsStarted 2020-08-01
Plain-language summary
Cardiovascular Disease (CVD) is a leading cause of death in the developed world. Atherosclerosis causes plaques in the blood vessels and is a common form of CVD. Inflammation is now recognized as a major cause of atherosclerosis. Therapies that target inflammation are being examined as a potential treatment option. Imaging to detect inflammation may be a solution to understand mechanisms and to optimize patient selection and outcomes for these drugs. Fluorodeoxyglucose (FDG) PET imaging can detect inflammation in the plaque and identify patients vulnerable to plaque rupture which cause events such as myocardial infarctions (MI) and strokes. The primary objective of this proposal(CADENCE) is to determine if the drug colchicine has an effect on plaque inflammation in patients at high risk for events (patients with diabetes or pre-diabetes and recent myocardial infarction, stroke or transient ischemic attacks (TIAs)). This mechanistic and proof-of-concept study will set the stage for future studies that will determine if inflammation imaging can be integrated into clinical practice to personalize decisions for anti-inflammation therapies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Type 2 Diabetes (on diet, oral hypo-glycemic agents and/or insulin) or pre-diabetes (defined by Diabetes Canada as HbA1C=6.0-6.45% or increased fasting blood sugar (FBS) (6.1-6.9 mmol/L) or impaired glucose tolerance);
. suffered a recent cardiovascular event (≤120 days post ACS (i.e. STEMI or nonSTEMI) or TIA/stroke with associated large vessel atherosclerotic disease confirmed on US, CT or MRI;
. stable symptoms and hemodynamics;
. age ≥18 years;
. given informed consent. Standard definitions will be used for STEMI, NSTEMI, and for ischemic stroke confirmed by CT or MRI and TIA confirmed by a neurologist.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested colchicine — a drug most people know for gout — in people with both diabetes and cardiovascular disease; can you explain why researchers thought it might help reduce artery inflammation in patients like me, and what that could mean for my situation?
2The trial measured something called FDG uptake TBR in artery segments, which is a way of imaging inflammation in blood vessels — is that type of imaging something I would need or benefit from as part of my own care, and what would the results tell us?
3Since this was a Phase 3 trial and recruitment is now completed, does that mean results should be available soon, and would those findings change how you think about managing inflammation as part of my diabetes or heart disease treatment?
4Colchicine is already an approved medication for other conditions — based on what this trial was studying, is there any reason it might or might not be appropriate for me to discuss as an add-on to my current treatment plan?
5Are there standard treatments already proven to reduce cardiovascular inflammation in people with diabetes that I should be prioritizing before considering anything that came out of a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6 month change in FDG uptake TBR (Tissue to Blood Ratio) in the MDS (Maximum Disease Segment)
Timeframe: 6 months
Trial details
NCT IDNCT04181996
SponsorOttawa Heart Institute Research Corporation
. planned revascularization of infarct or stroke related artery more than 120 days after the qualifying/index event;
. a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist;
. recent CV event likely to have been secondary to myocardial infarction with non-obstructive coronary arteries (MINOCA) in the opinion of the cardiologist;
. severe LV dysfunction (EF\<30%);
. severe valve disease requiring intervention;
. decompensated heart failure;
. active infection (e.g. pneumonia, active skin infections, and on antibiotics);