CLINICAL TRIAL

Notification for Coronary Artery Disease

EnrollingByInvitation · 18+ · All Sexes · Stanford, CA

This study is evaluating whether a simple notification of incidental coronary artery calcium on a chest CT leads to a higher rate of statin prescription.

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About the trial for Coronary Artery Disease

Eligible Conditions
Cardiovascular Diseases · Atherosclerosis · Coronary Artery Disease · Atherosclerotic Cardiovascular Diseases

Treatment Groups

This trial involves 2 different treatments. Notification is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Notification
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A Stanford affiliated primary care provider or endocrinologist is a healthcare system patient's primary care provider, and a VA primary care provider is a VA patient's primary care provider if they have had at least 1 encounter since 2018. show original
were associated with increased mortality Non-gated chest CT scans performed between 2014 and 2019 were associated with an increased risk of death. show original
The presence of CAC was confirmed by manual review by an experienced radiologist. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Notification will improve 1 primary outcome and 14 secondary outcomes in patients with Coronary Artery Disease. Measurement will happen over the course of Within 6 months.

Rate of Statin Prescription
WITHIN 6 MONTHS
Proportion of patients prescribed a statin
WITHIN 6 MONTHS
Body Mass Index
6 MONTHS
6 MONTHS
Number of Cardiology Referrals
6 MONTHS
6 MONTHS
Total Cholesterol Level
6 MONTHS
6 MONTHS
Systolic Blood Pressure
6 MONTHS
6 MONTHS
Hemoglobin A1c Level
6 MONTHS
6 MONTHS
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Who is running the study

Principal Investigator
A. S.
Alexander Sandhu, Principal Investigator, Instructor of Medicine, Division of Cardiology
Stanford University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of coronary artery disease?

Symptoms of coronary artery disease can be mistaken for other diseases or signs of aging. The best way to diagnose coronary artery disease is by using an electrocardiogram (ECG) with the help of a computer. A physician can then choose the right treatment plan to help them feel better. Once diagnosed, coronary artery disease is one of the few things that can be effectively treated. One way to treat coronary artery disease is by using lipid-lowering medications such as statins. Statins are very effective at lower doses than needed for the treatment of high blood cholesterol, which is often found in coronary artery disease. At higher doses, statins can cause muscle pain and tenderness if the person is inactive and not exercising regularly.

Anonymous Patient Answer

Can coronary artery disease be cured?

At age 76, one-third of subjects with a history of angiodysplasia have no evidence of plaques or of stenosis, and half have only minimal burden of disease. However, a history of angiodysplasia is strongly associated with more than a quarter of subjects with angiographically documented coronary artery disease. Results from a recent clinical trial are consistent with a 'biological hypothesis' that the angiodysplastic plaques may be 'benign' in some subjects.

Anonymous Patient Answer

What is coronary artery disease?

In the UK in 2014, there were 12,6,000 new cases of CAD. The most recent data, that of the English National Health Service (NHS), show that the number of new cases of CAD in England had a five-fold increase from 2002 to 2015 – from 13,000 a year in 2002 to 79,000 in 2015. The increase was almost totally attributable to rises in women with CAD (from 36,000 in 2002 to 100,000 in 2015). Diabetes was the major concurrent risk factor for both men and women (28% and 24%).

Anonymous Patient Answer

How many people get coronary artery disease a year in the United States?

About 22.3 million Americans will have a myocardial infarction in 2006. The total numbers of patients with coronary stenosis or coronary revascularization and patients with symptoms suggestive of coronary artery disease from all ages are about 35.9 million. It is unclear to what extent this "silent disease" remains asymptomatic for the elderly patient.

Anonymous Patient Answer

What are common treatments for coronary artery disease?

The treatment of coronary artery disease is complex and depends not just on the disease's etiology, but also on the physical characteristics of the patient such as age and medical history. There is no cure for coronary artery disease, and treatment is focussed on symptom relief and preventing complications. There is not enough evidence here to establish whether medication or medical therapy is better for most patients. The medications recommended are often prescribed in high dosages, which can lead to undesirable side-effects. There is no evidence that aspirin used to prevent clots, although this treatment is commonly suggested.

Anonymous Patient Answer

What causes coronary artery disease?

The coronary artery disease may have multiple risk factors, including age, genetics, physical inactivity, stress, smoking, and elevated levels of blood pressure – especially low-dose exposure to radiation from nuclear explosions. The cause of coronary artery disease appears to be the first step, perhaps from a complex interaction among biological, social and environmental factors.

Anonymous Patient Answer

Have there been any new discoveries for treating coronary artery disease?

The therapeutic effects of PCI were similar to those of CABG. In conclusion, PCI has advantages as a safe and efficient method of revascularization. It was a better method in patients with severe CAD than CABG, as well as in the treatment of patients with stable or unstable angina.

Anonymous Patient Answer

Does notification improve quality of life for those with coronary artery disease?

We found that, compared to those who received a letter from their physician, those who received an additional educational letter from their healthcare provider improved only on the short range: they reported better perceived health status when asked immediately after receiving the letter and 4 months later. If more rigorous studies with larger sample sizes validate this observation, it might be possible to implement clinical decision support systems aiming at increasing the detection and diagnosis of coronary artery disease.

Anonymous Patient Answer

What is notification?

Most GPs do not regularly notify patients of their cardiovascular disease risk, leading patients to delay diagnosis. A patient's cardiovascular disease risk may be underestimated and appropriate preventive measures not taken.

Anonymous Patient Answer

What are the latest developments in notification for therapeutic use?

There has been some movement in informing patients about the use of the new drug before it is approved. There needs to be more cooperation by all stakeholders (e.g. medical associations, regulators) in order to reach consensus to improve patient safety in evaluating new drugs.

Anonymous Patient Answer

Who should consider clinical trials for coronary artery disease?

Patients with low Framingham scores and previous ACS should be prioritized for clinical trials testing revascularization strategies for CABG since these strategies can significantly reduce the long-term risk of death.

Anonymous Patient Answer

What are the common side effects of notification?

A high percentage of patients (40%) reported side effects after sending notification letters and receiving the letter and number of patients (41%) reported side effects postoperatively. Although the majority of side effects in this study were benign, they were statistically significant. There was no significant correlation between age and side effects.

Anonymous Patient Answer
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