Patient Education for Cardiovascular Health

Not currently recruiting at 1 trial location

Overseen By Etta Pisano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American College of Radiology

Disqualifiers: Cad, Prior heart surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether educational letters about coronary artery calcification (a build-up of calcium in the heart's arteries) can encourage healthier choices to reduce heart disease risk. The focus is on individuals in lung cancer screening programs. Participants will either receive an informational letter or be part of a group that does not receive the letter. This trial may suit individuals who have smoked heavily in the past or are current smokers and have recently undergone a low-dose CT scan for lung cancer screening. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance health education strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this educational intervention is safe?

Research has shown that using coronary artery calcium (CAC) scoring in CT scans is generally safe. In one study, 98% of patients who underwent CT calcium scoring were alive after five years, compared to 95% of those who did not. This suggests the procedure is safe and does not cause serious side effects.

In this trial, patients receive an educational letter after the CT scan. This letter explains their coronary calcium score and its implications for heart disease risk. As it is purely educational, it involves no physical treatment or medication and thus lacks the usual risks associated with medical treatments.

In summary, the educational letter is safe because it simply provides information to help patients understand and manage their heart health better. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve cardiovascular health through patient education. Unlike traditional treatments that focus on medications or procedures to manage heart health, this approach involves sending an educational letter to patients after a CT scan. The letter provides personalized information, including their coronary calcium score, and educational materials aimed at empowering patients to make informed lifestyle changes. This method emphasizes prevention and self-management, potentially leading to better long-term outcomes by encouraging proactive health behaviors.

What evidence suggests that this educational intervention is effective for cardiovascular risk modification?

Research shows that knowing one's coronary artery calcium (CAC) score can help predict the risk of heart disease. Studies have found that when people learn their CAC score, they often make positive lifestyle changes, such as eating healthier or exercising more. These changes are important because they can reduce the risk of heart disease. A review found that people who knew their CAC scores were more likely to take steps to improve their heart health. In this trial, participants in the "Letter Recipients with Coronary Calcium Score/Educational Materials" arm will receive an educational letter based on their CAC scores. Evidence suggests that knowing one's CAC score can encourage healthier choices. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for current or former smokers aged 50-80 who've had a low-dose CT scan for lung cancer screening within the last month. Participants should have smoked more than 20 pack-years. Those with known coronary artery disease, past heart surgeries, language barriers, or without stable contact information cannot join.

Inclusion Criteria

I am between 50 and 80 years old.

I am currently smoking or quit smoking within the last 15 years.

I had a low-dose CT scan for lung cancer within the last 30 days.

Exclusion Criteria

I have a history of heart disease or have had heart surgery.

Patients unable to understand the informed consent process

Patients without a contact phone number or permanent address to receive the study intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment

Participants complete a baseline questionnaire on demographics, cardiovascular health, and lifestyle habits

1-2 weeks

1 visit (virtual)

Intervention

Participants in the intervention group receive an educational letter based on coronary calcium score

8 weeks

1 visit (virtual or mail)

Follow-up

Participants complete a follow-up questionnaire to assess changes in lifestyle and cardiovascular health

6 months

1 visit (virtual or mail)

What Are the Treatments Tested in This Trial?

Interventions

• Educational Letter Post CT Examination

Trial Overview The study evaluates if an educational letter about heart health sent after a CT scan can help people understand and manage their risk of heart disease better. It's conducted by ACR CRI across multiple centers and randomly assigns patients to receive this intervention.

How Is the Trial Designed?

Group I: Letter Recipients with Coronary Calcium Score/Educational Materials Experimental Treatment 1 Intervention

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Group II: Non-Letter Recipients (Control) Active Control 1 Intervention

Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials.

Who Is Running the Clinical Trial?

American College of Radiology

Lead Sponsor

Trials

24

Recruited

8,055,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9885234/

An update on the coronary calcium score: a review for ... In this review, we discuss the methods of CAC evaluation, the meaning of a zero CAC score (CACS), its conversion to CACS > 0 and the impact of this fact on ...

2. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.210122

Coronary Artery Calcium Scoring: Current Status and ... Coronary artery calcium (CAC) scores obtained from CT scans have been shown to be prognostic in assessment of the risk for development of ...

3. ahajournals.org ahajournals.org/doi/10.1161/circimaging.113.000092

Validation and Prognosis of Coronary Artery Calcium ... Coronary calcium score (CS), traditionally based on electrocardiography-triggered computed tomography (CT), predicts cardiovascular risk.

4. opencardiovascularmedicinejournal.com opencardiovascularmedicinejournal.com/VOLUME/2/PAGE/87/FULLTEXT/

Coronary Artery Calcium Scores: Current Thinking and ... This review tries to synthesize the current literature on coronary artery calcium and its detection by CT as a tool for risk assessment. We have also ...

5. mdpi.com mdpi.com/2076-3417/14/19/8906

Evidence-Based Investigation of Coronary Calcium Score ... This study aimed to verify whether increased body mass index (BMI) increases the noise in computed tomography (CT) images due to heightened effective thickness ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443952/

Coronary calcium by computed tomography and outcomes 98% of the patients who underwent computed tomography (CT) calcium scoring surviving at 5 years as opposed to only 95% of those who did not undergo CT calcium ...

7. mayoclinic.org mayoclinic.org/tests-procedures/heart-scan/about/pac-20384686

Coronary calcium scan This heart CT test can show calcium deposits in the blood vessels. Know how the findings relate to your heart disease risk.

8. mdpi.com mdpi.com/2076-3417/13/1/241

Beyond the Calcium Score: What Additional Information ... This review aims to describe all CT potential in atherosclerosis detection and cardiovascular risk assessment beyond the CAC.

9. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=33423&ver=51

Cardiac Computed Tomography & Angiography (CCTA) Use this page to view details for the Local Coverage Determination for Cardiac Computed Tomography & Angiography (CCTA).