Coronary Artery DiseaseNCT06055972
Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health
A study testing Educational Letter Post CT Examination in people with Coronary Artery Disease and Cardiovascular Diseases, run by American College of Radiology at 2 sites in United States.
Trial summary
This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Cardiovascular Diseases, Smoking
- What is being tested?
- Educational Letter Post CT Examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2023to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 80 years old
- More than 20 pack years of smoking
- Actively smoking or previous smokers who quit with the last 15 years
- Completed a Low-dose CT Scan for Lung Cancer Screening within 30 day of registration
Who cannot join
- Patients unable to understand the informed consent process
- Patients without a contact phone number or permanent address to receive the study intervention.
- Patients who do not understand the English language
- Patients with known CAD or prior heart surgery /intervention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michagan
Ann Arbor, Michigan, 48109
University of Washington
Seattle, Washington, 98195
About this study
This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
Read the detailed description
Objectives:
The overall goal of the proposed study is to improve cardiovascular health of smokers and previous smokers, as CAD is the most common cause of death in this population. Patients enrolled in lung cancer screening programs compose a highly suitable cohort of heavy smokers and previous smokers with 55-80 years of age for testing interventions that could improve the cardiovascular health of the population
The objective is to use coronary artery calcification burden, derived from computed tomography studies obtained for lung cancer screening purposes, to motivate patients into improving their health habits. The specific goal of this study is to test the efficacy of a patient-centered educational intervention based on CAC information in appropriate statin use and cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
Recruitment:
Patients will be sent a mail or email research packet containing the invitation to join the study, the consent form and the baseline survey. Alternatively, patients could receive a phone call regarding information about the study
Consenting:
Following screening for eligibility, IRB-approved, HIPAA-compliant informed consent will be obtained by the Research Coordinators medical at the two participating institutions Patient registration can occur only after evaluation for eligibility is complete, eligibility criteria have been met, and the study site is approved by the ACR. Participants must have signed and dated all applicable informed consents and authorization forms.
Randomization:
Investigators will randomly select (coin flipping) first month as intervention yes/no and then alternate monthly until the end of the enrollment period. Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.
Baseline Questionnaire:
After consent form is signed, patients will have the option to either complete research questionnaire independently or with the help of the research coordinator over a virtual visit Patient will then mail or email the survey back to the research coordinator.
Patient's demographics and socioeconomic status will be inquired including age, gender, gender-identity and race/ethnicity, level of education, range of income, and health insurance status. The baseline cardiovascular health questionnaire will include data on lifestyle and eating habits, smoking status, known cardiovascular diseases, previous cardiovascular interventions, known cardiovascular risk factors such as obesity, hypercholesterolemia, hypertension, family history of heart disease, current use of statins or aspirin, current recommendation to use Statins or aspirin, willingness to pursue lifestyle modifications to reduce cardiovascular risk, and co-morbidities.
An exercise activity level questionnaire (IPAQ-7), a standardized anxiety questionnaire (GAD-7) and a patient activation questionnaire (PAM short) will also be applied.
In addition to data obtained in the baseline questionnaire, medical records, when available, will be reviewed for confirmation of height, weight, and blood pressure at the time of lung cancer screening appointment.
6-Month Follow Up Questionnaire: Approximately 6 months after consent, patients will receive the follow up mail or email research packet containing the follow up questionnaire. Alternatively, patients can receive a follow-up phone call to review the questionnaire. Questionnaire will address the main study outcomes including changes in lifestyle like exercise habit (IPAQ-7), smoking cessation, weight loss, initiation or dose change of Statin or aspirin, adherence to statin or aspirin prescription, level of anxiety (GAD-7), activation level for health self-care (PAM-short), number of cardiovascular imaging tests (echocardiography, catheterization, cardiac stress test, cardiac CT or cardiac MR) performed, and number of clinical visits motivated by the intervention or not.
Image Analysis for Coronary Artery Calcium Quantification:
All patients will have received a Low Dose CT of the chest for Lung cancer screening, as part of their clinical care. The LCS CT images will be analyzed by the site chest radiologist as per clinical care, and the report will include a qualitative statement on burden of coronary artery calcifications (none, mild, moderate, or severe), based on current guideline recommendations. In patients randomized to the intervention arm, quantification of calcium score using the Agatston score method will be performed by a member of the research team and reviewed by study site PI.
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Smoking
- Being tested
- Educational Letter Post CT Examination
- Keywords
- Coronary Artery Calcification, Patient-Centered Approach, Lung Cancer Screening
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Letter Post CT ExaminationOther
Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination which will include the following:
- Their calcium score, brief educational content explaining what the calcium score means and how the presence of coronary calcifications is associated with an increased risk of a cardiac event.
- Guidance on what actions could be taken to decrease the risk of a heart event, including blood cholesterol management, smoking cessation, weight loss, dieting, exercise, and blood pressure control.
- For patients with CAC>0, the letter will encourage the patient to pursue a shared decision- making discussion with his/her primary care physician or cardiologist regarding risk reduction strategies.
- Links to American Heart Association (AHA) and phone number for study research coordinator.
| Study group | Role | What they receive |
|---|---|---|
| Letter Recipients with Coronary Calcium Score/Educational Materials | Experimental | Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination. Receives: Other: Educational Letter Post CT Examination |
| Non-Letter Recipients (Control) | No intervention | Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline-Appropriate High Cholesterol Care
Rate of statin use (how often patients are required to take statin medications) and adherence (how often patents comply with taking statin medications as prescribed) to prescription in patients with known hypercholesterolemia. This will be determined by patients' self-reported answers to questions during interviews and review of medical records. Both rate of statin use and patient compliance will be used to generate a single, overall assessment of how well patients are being treated for and managing their hypercholesteremia.
Measured: 6 Months
Exercise Level
Changes in exercise level, surveyed using International Physical Activity Questionnaire (IPAQ-short) questionnaire. The IPAQ-short questionnaire is comprised of 7, self-reported, open-ended questions surrounding individuals' last 7-day recall of physical activity. The questionnaire estimates the total physical activity in Metabolic Equivalent of Task (METs)- min/week and time spent sitting. Scores vary depending on the person's activity level throughout the preceding 7 days, and there is not defined range for scores, as the questions are open ended (e.g. How many hours did you spend doing vigorous activities during the last 7days?).
Measured: 6 Months
Patient Self-Reported Smoking Habits and Cessation
Patients' self-reported smoking habits will be assessed via phone call or questionnaire at baseline and 6-month follow-up.
Measured: 6 Months
Weight loss
Patient reported weight changes
Measured: 6 Months
Blood Pressure Control
Patient reported blood pressure changes and initiation of anti-hypertensive therapy. Both systolic/diastolic blood pressure will be measured.
Measured: 6 Months
Patient Anxiety
Patient anxiety, measured by changes in Generalize Anxiety Disorder-7 (GAD-7) anxiety questionnaire 6 months after intervention. The GAD-7 questionnaire is rated on a scale from 0-21, with higher scores indicating higher patient self-reported anxiety levels.
Measured: 6 Months
Number of Invasive/Noninvasive Hospitalizations
Clinical visits, cardiac imaging tests, and hospitalizations 6 months after the intervention, to be measured by medical record review (to be assessed by research coordinator at 6 month follow-up) and follow up phone survey (patient self-reporting). Number of visits, obtained from both the patient interview and patient medical records, for both invasive and noninvasive hospitalizations, will be combined to generate a single number, or complete total number of visits patients have experienced 6 months after intervention.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Dec 2023
- Primary completion2 Jun 2025
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055972
- Sponsor's protocol ID
- ACR 4708
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual patient data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT06055972
- Acronym / sponsor ID
- ACR 4708
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Smoking
- Keywords
- Coronary Artery Calcification, Patient-Centered Approach, Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- American College of RadiologyUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
Detailed description
Objectives:
The overall goal of the proposed study is to improve cardiovascular health of smokers and previous smokers, as CAD is the most common cause of death in this population. Patients enrolled in lung cancer screening programs compose a highly suitable cohort of heavy smokers and previous smokers with 55-80 years of age for testing interventions that could improve the cardiovascular health of the population
The objective is to use coronary artery calcification burden, derived from computed tomography studies obtained for lung cancer screening purposes, to motivate patients into improving their health habits. The specific goal of this study is to test the efficacy of a patient-centered educational intervention based on CAC information in appropriate statin use and cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.
Recruitment:
Patients will be sent a mail or email research packet containing the invitation to join the study, the consent form and the baseline survey. Alternatively, patients could receive a phone call regarding information about the study
Consenting:
Following screening for eligibility, IRB-approved, HIPAA-compliant informed consent will be obtained by the Research Coordinators medical at the two participating institutions Patient registration can occur only after evaluation for eligibility is complete, eligibility criteria have been met, and the study site is approved by the ACR. Participants must have signed and dated all applicable informed consents and authorization forms.
Randomization:
Investigators will randomly select (coin flipping) first month as intervention yes/no and then alternate monthly until the end of the enrollment period. Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.
Baseline Questionnaire:
After consent form is signed, patients will have the option to either complete research questionnaire independently or with the help of the research coordinator over a virtual visit Patient will then mail or email the survey back to the research coordinator.
Patient's demographics and socioeconomic status will be inquired including age, gender, gender-identity and race/ethnicity, level of education, range of income, and health insurance status. The baseline cardiovascular health questionnaire will include data on lifestyle and eating habits, smoking status, known cardiovascular diseases, previous cardiovascular interventions, known cardiovascular risk factors such as obesity, hypercholesterolemia, hypertension, family history of heart disease, current use of statins or aspirin, current recommendation to use Statins or aspirin, willingness to pursue lifestyle modifications to reduce cardiovascular risk, and co-morbidities.
An exercise activity level questionnaire (IPAQ-7), a standardized anxiety questionnaire (GAD-7) and a patient activation questionnaire (PAM short) will also be applied.
In addition to data obtained in the baseline questionnaire, medical records, when available, will be reviewed for confirmation of height, weight, and blood pressure at the time of lung cancer screening appointment.
6-Month Follow Up Questionnaire: Approximately 6 months after consent, patients will receive the follow up mail or email research packet containing the follow up questionnaire. Alternatively, patients can receive a follow-up phone call to review the questionnaire. Questionnaire will address the main study outcomes including changes in lifestyle like exercise habit (IPAQ-7), smoking cessation, weight loss, initiation or dose change of Statin or aspirin, adherence to statin or aspirin prescription, level of anxiety (GAD-7), activation level for health self-care (PAM-short), number of cardiovascular imaging tests (echocardiography, catheterization, cardiac stress test, cardiac CT or cardiac MR) performed, and number of clinical visits motivated by the intervention or not.
Image Analysis for Coronary Artery Calcium Quantification:
All patients will have received a Low Dose CT of the chest for Lung cancer screening, as part of their clinical care. The LCS CT images will be analyzed by the site chest radiologist as per clinical care, and the report will include a qualitative statement on burden of coronary artery calcifications (none, mild, moderate, or severe), based on current guideline recommendations. In patients randomized to the intervention arm, quantification of calcium score using the Agatston score method will be performed by a member of the research team and reviewed by study site PI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letter Recipients with Coronary Calcium Score/Educational Materials | Experimental | Other: Educational Letter Post CT ExaminationPatients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination. |
| Non-Letter Recipients (Control) | No intervention | –Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 50 to 80 years old
- More than 20 pack years of smoking
- Actively smoking or previous smokers who quit with the last 15 years
- Completed a Low-dose CT Scan for Lung Cancer Screening within 30 day of registration
Key exclusion criteria (4 listed)
- Patients unable to understand the informed consent process
- Patients without a contact phone number or permanent address to receive the study intervention.
- Patients who do not understand the English language
- Patients with known CAD or prior heart surgery /intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Letter Post CT ExaminationPatients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination which will include the following: 1. Their calcium score, brief educational content explaining what the calcium score means and how the presence of coronary calcifications is associated with an increased risk of a cardiac event. 2. Guidance on what actions could be taken to decrease the risk of a heart event, including blood cholesterol management, smoking cessation, weight loss, dieting, exercise, and blood pressure control. 3. For patients with CAC>0, the letter will encourage the patient to pursue a shared decision- making discussion with his/her primary care physician or cardiologist regarding risk reduction strategies. 4. Links to American Heart Association (AHA) and phone number for study research coordinator. | Other | Letter Recipients with Coronary Calcium Score/Educational Materials |
Primary outcome
Guideline-Appropriate High Cholesterol Care
Time frame: 6 Months
Rate of statin use (how often patients are required to take statin medications) and adherence (how often patents comply with taking statin medications as prescribed) to prescription in patients with known hypercholesterolemia. This will be determined by patients' self-reported answers to questions during interviews and review of medical records. Both rate of statin use and patient compliance will be used to generate a single, overall assessment of how well patients are being treated for and managing their hypercholesteremia.
Exercise Level
Time frame: 6 Months
Changes in exercise level, surveyed using International Physical Activity Questionnaire (IPAQ-short) questionnaire. The IPAQ-short questionnaire is comprised of 7, self-reported, open-ended questions surrounding individuals' last 7-day recall of physical activity. The questionnaire estimates the total physical activity in Metabolic Equivalent of Task (METs)- min/week and time spent sitting. Scores vary depending on the person's activity level throughout the preceding 7 days, and there is not defined range for scores, as the questions are open ended (e.g. How many hours did you spend doing vigorous activities during the last 7days?).
Patient Self-Reported Smoking Habits and Cessation
Time frame: 6 Months
Patients' self-reported smoking habits will be assessed via phone call or questionnaire at baseline and 6-month follow-up.
Weight loss
Time frame: 6 Months
Patient reported weight changes
Blood Pressure Control
Time frame: 6 Months
Patient reported blood pressure changes and initiation of anti-hypertensive therapy. Both systolic/diastolic blood pressure will be measured.
Patient Anxiety
Time frame: 6 Months
Patient anxiety, measured by changes in Generalize Anxiety Disorder-7 (GAD-7) anxiety questionnaire 6 months after intervention. The GAD-7 questionnaire is rated on a scale from 0-21, with higher scores indicating higher patient self-reported anxiety levels.
Number of Invasive/Noninvasive Hospitalizations
Time frame: 6 Months
Clinical visits, cardiac imaging tests, and hospitalizations 6 months after the intervention, to be measured by medical record review (to be assessed by research coordinator at 6 month follow-up) and follow up phone survey (patient self-reporting). Number of visits, obtained from both the patient interview and patient medical records, for both invasive and noninvasive hospitalizations, will be combined to generate a single number, or complete total number of visits patients have experienced 6 months after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual patient data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Letter Post CT Examination in people with Coronary Artery Disease and Cardiovascular Diseases, run by American College of Radiology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline-Appropriate High Cholesterol Care (time frame: 6 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.