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Cardiovascular Risk Management for Type 2 Diabetes (CVRiD Trial)
N/A
Recruiting
Research Sponsored by American College of Cardiology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T2D diagnosis in the medical record
ASCVD, defined as known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
CVRiD Trial Summary
This trial aims to improve care of patients with T2D by providing better resources and support for physicians to use recommended treatments to reduce CV risk.
Who is the study for?
This trial is for adults with type 2 diabetes who have a history of cardiovascular issues like stroke, artery disease, or heart problems. They must not be on certain diabetes medications (SGLT2i or GLP-1RA), have severe liver disease, pancreatitis, cancer, less than a year to live, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests how decision support tools and referrals to specialized cardiometabolic care can improve the use of treatments that lower heart risk in people with type 2 diabetes. It's about finding best practices in real-world medical settings.See study design
What are the potential side effects?
Since this trial focuses on practice patterns and quality improvement rather than specific drugs or devices, it does not directly involve side effects from interventions. However, changes in treatment as a result of the trial may carry their own risks.
CVRiD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes.
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I have a history of heart disease, including heart attack or procedures to open my heart's arteries.
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I have had artery disease in my legs, including treatments to improve blood flow.
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I have had a stroke, TIA, or surgery to open my neck arteries.
CVRiD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
New prescription of a SGLT2i and/or GLP-1RA
CVRiD Trial Design
3Treatment groups
Active Control
Group I: Education aloneActive Control1 Intervention
Group II: Education + decision support to provide suggestions for care optimizationActive Control1 Intervention
Group III: Education + facilitated referral to cardiometabolic team-based center for care optimizationActive Control1 Intervention
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Who is running the clinical trial?
American College of CardiologyLead Sponsor
17 Previous Clinical Trials
325,236 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,514 Previous Clinical Trials
2,414,318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart disease, including heart attack or procedures to open my heart's arteries.I have a history of medullary thyroid cancer or MEN-2.You are currently taking part in a study testing a new drug or medical device, except for studies related to COVID-19.You have had a heart transplant or have plans to get a ventricular assist device.I have had artery disease in my legs, including treatments to improve blood flow.I am currently receiving comfort care or am enrolled in hospice.I have had a stroke, TIA, or surgery to open my neck arteries.I have been diagnosed with Type 2 Diabetes.I have had diabetic ketoacidosis in the past.I am currently taking medication for diabetes.I have had Fournier's Gangrene before.You have type 1 diabetes.I am allergic or intolerant to SGLT2 inhibitors or GLP-1 receptor agonists.I have had pancreatitis or pancreatic cancer.My liver is severely damaged and cannot function properly.You are not expected to live for more than a year.I am currently on or planning to start hemodialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Education alone
- Group 2: Education + decision support to provide suggestions for care optimization
- Group 3: Education + facilitated referral to cardiometabolic team-based center for care optimization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh participants being sought for this clinical trial?
"The clinical study, which was initially published on September 1st 2023, is currently recruiting participants; the most recent update to its information occurred July 13th 2023."
Answered by AI
What is the estimated sample size of this experiment?
"Correct. According to clinicaltrials.gov, this medical trial is still taking in participants from the time it was first posted on September 1st 2023 up until its most recent update on July 13th 2023. The study requires 750 patients from a single site for full enrolment."
Answered by AI
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