Cardiovascular Risk FactorCLARIFYNCT04075162
Community Benefit of No-charge Calcium Score Screening Program
An observational study of Cardiovascular Risk Factor, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Current approaches in primary prevention for cardiovascular disease are based on probabilistic approaches to estimate risk, using many of the widely available cardiovascular risks scores, with over 100 such scoring systems currently available throughout the world. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiovascular Risk Factor
- How many people
- 77,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients who received a no-cost Coronary Artery Calcium (CAC) CT scan at University Hospitals (Cleveland, Oh) starting in January 1, 2014.
Who may be able to join
- Received Coronary Artery Calcium (CAC) CT scan at University Hospitals starting in January 1, 2014.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Clinical Research Specialist, 2168445125
About this study
Current approaches in primary prevention for cardiovascular disease are based on probabilistic approaches to estimate risk, using many of the widely available cardiovascular risks scores, with over 100 such scoring systems currently available throughout the world. The rationale for this practice is to select those individuals at greatest risk for more intense targets, reduce risk of treatment to those at minimal risk, and to maximize the cost-effectiveness of treatment. A recent Cochrane Systematic Review assessed the practice of using risk scores to select individuals for the primary prevention of cardiovascular disease. 3 The principal finding of the systematic review was that there was little or no effect of providing clinicians with cardiovascular risk scores when compared to standard of care (5.4% versus 5.3%; relative risk 1.01, 95% confidence intervals 0.95 to 1.08). The authors concluded that there is major uncertainty whether current strategies for providing risk scores and called for further research to address this concern. Extent of coronary artery calcium (CAC) is a strong risk marker for coronary events, with evidence mainly derived from observational studies and from prospective non-randomized studies. CAC, although endorsed for intermediate risk patients, is not widely adopted due to barriers in reimbursement. The cost of the test ranges between 100 and 300 USD in the United States, which may have limited the wide adoption of the test. Whether reducing the cost burden for CAC increases utilization for routine screening and its influence on physician practices and downstream testing is largely unknown. University Hospitals started offering low charge CAC (99$) since 2014. In 2017, University Hospitals started offering CAC for no charge for patients to improve access to this test, which has not traditionally been covered by insurance companies. The impact of no-charge CAC has never been studied.
- Conditions
- Cardiovascular Risk Factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low charge CAC | Patients receiving CAC for Cardiovascular disease risk screening at low charge (99 USD) | |
| No charge CAC | Patients receiving CAC for Cardiovascular disease risk screening at no charge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin Prescription
Measured: 1 year
Secondary outcomes (3)
Non-invasive coronary ischemia testing
Stress echocardiograms, myocardial perfusion imaging
Measured: 1 year
Invasive coronary ischemia testing
Invasive coronary angiography
Measured: 1 year
Coronary revascularization procedures
Percutaneous coronary interventions, coronary artery bypass grafting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study startJan 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 77,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Rajagopalan, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075162
- Sponsor's protocol ID
- 20190995
- Acronym
- CLARIFY
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2019
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh P, Hoori A, Freeze J, Hu T, Tashtish N, Gilkeson R, Li S, Rajagopalan S, Wilson DL, Al-Kindi S. Leveraging calcium score CT radiomics for heart failure risk prediction. Sci Rep. 2024 Nov 6;14(1):26898. doi: 10.1038/s41598-024-77269-x.
PubMed 39505933Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Rajagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. Sci Rep. 2024 May 15;14(1):11134. doi: 10.1038/s41598-024-60584-8.
PubMed 38750142Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Ra-Jagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. ArXiv [Preprint]. 2023 Aug 23:arXiv:2308.12224v1.
PubMed 37664409Siva Kumar S, Al-Kindi S, Tashtish N, Rajagopalan V, Fu P, Rajagopalan S, Madabhushi A. Machine learning derived ECG risk score improves cardiovascular risk assessment in conjunction with coronary artery calcium scoring. Front Cardiovasc Med. 2022 Oct 5;9:976769. doi: 10.3389/fcvm.2022.976769. eCollection 2022.
PubMed 36277775Al-Kindi S, Tashtish N, Rashid I, Sullivan C, Neeland IJ, Robinson M, Gross EM, Shaw L, Cainzos-Achirica M, Nasir K, Kreatsoulas C, Gilkeson R, Simon DI, Rajagopalan S. Impact of low/no-charge coronary artery calcium scoring on statin eligibility and outcomes in women: The CLARIFY study. Am J Prev Cardiol. 2022 Sep 11;12:100392. doi: 10.1016/j.ajpc.2022.100392. eCollection 2022 Dec.
PubMed 36157553Khawaja T, Janus SE, Tashtish N, Janko M, Baeza C, Gilkeson R, Al-Kindi SG, Rajagopalan S. Prevalence of thoracic aortic aneurysm in patients referred for no/low-charge coronary artery calcium scoring: Insights from the CLARIFY registry. Am J Prev Cardiol. 2022 Aug 30;12:100378. doi: 10.1016/j.ajpc.2022.100378. eCollection 2022 Dec.
PubMed 36106308
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Benefit of No-charge Calcium Score Screening Program
- ClinicalTrials.gov ID
- NCT04075162
- Acronym / sponsor ID
- CLARIFY / 20190995
- Conditions
- Cardiovascular Risk Factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 77,000 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Aug 2019 (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.
Current approaches in primary prevention for cardiovascular disease are based on probabilistic approaches to estimate risk, using many of the widely available cardiovascular risks scores, with over 100 such scoring systems currently available throughout the world. The rationale for this practice is to select those individuals at greatest risk for more intense targets, reduce risk of treatment to those at minimal risk, and to maximize the cost-effectiveness of treatment. A recent Cochrane Systematic Review assessed the practice of using risk scores to select individuals for the primary prevention of cardiovascular disease. 3 The principal finding of the systematic review was that there was little or no effect of providing clinicians with cardiovascular risk scores when compared to standard of care (5.4% versus 5.3%; relative risk 1.01, 95% confidence intervals 0.95 to 1.08). The authors concluded that there is major uncertainty whether current strategies for providing risk scores and called for further research to address this concern. Extent of coronary artery calcium (CAC) is a strong risk marker for coronary events, with evidence mainly derived from observational studies and from prospective non-randomized studies. CAC, although endorsed for intermediate risk patients, is not widely adopted due to barriers in reimbursement. The cost of the test ranges between 100 and 300 USD in the United States, which may have limited the wide adoption of the test. Whether reducing the cost burden for CAC increases utilization for routine screening and its influence on physician practices and downstream testing is largely unknown. University Hospitals started offering low charge CAC (99$) since 2014. In 2017, University Hospitals started offering CAC for no charge for patients to improve access to this test, which has not traditionally been covered by insurance companies. The impact of no-charge CAC has never been studied.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low charge CAC | – | –Patients receiving CAC for Cardiovascular disease risk screening at low charge (99 USD) |
| No charge CAC | – | –Patients receiving CAC for Cardiovascular disease risk screening at no charge |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who received a no-cost Coronary Artery Calcium (CAC) CT scan at University Hospitals (Cleveland, Oh) starting in January 1, 2014.
Key inclusion criteria (1 listed)
- Received Coronary Artery Calcium (CAC) CT scan at University Hospitals starting in January 1, 2014.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Statin Prescription
Time frame: 1 year
3 secondary outcomes
Non-invasive coronary ischemia testing
Time frame: 1 year
Invasive coronary ischemia testing
Time frame: 1 year
Coronary revascularization procedures
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 39505933Singh P, Hoori A, Freeze J, Hu T, Tashtish N, Gilkeson R, Li S, Rajagopalan S, Wilson DL, Al-Kindi S. Leveraging calcium score CT radiomics for heart failure risk prediction. Sci Rep. 2024 Nov 6;14(1):26898. doi: 10.1038/s41598-024-77269-x.
- Derived from this study: PubMed 38750142Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Rajagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. Sci Rep. 2024 May 15;14(1):11134. doi: 10.1038/s41598-024-60584-8.
- Derived from this study: PubMed 37664409Hoori A, Al-Kindi S, Hu T, Song Y, Wu H, Lee J, Tashtish N, Fu P, Gilkeson R, Ra-Jagopalan S, Wilson DL. Enhancing cardiovascular risk prediction through AI-enabled calcium-omics. ArXiv [Preprint]. 2023 Aug 23:arXiv:2308.12224v1.
- Derived from this study: PubMed 36277775Siva Kumar S, Al-Kindi S, Tashtish N, Rajagopalan V, Fu P, Rajagopalan S, Madabhushi A. Machine learning derived ECG risk score improves cardiovascular risk assessment in conjunction with coronary artery calcium scoring. Front Cardiovasc Med. 2022 Oct 5;9:976769. doi: 10.3389/fcvm.2022.976769. eCollection 2022.
- Derived from this study: PubMed 36157553Al-Kindi S, Tashtish N, Rashid I, Sullivan C, Neeland IJ, Robinson M, Gross EM, Shaw L, Cainzos-Achirica M, Nasir K, Kreatsoulas C, Gilkeson R, Simon DI, Rajagopalan S. Impact of low/no-charge coronary artery calcium scoring on statin eligibility and outcomes in women: The CLARIFY study. Am J Prev Cardiol. 2022 Sep 11;12:100392. doi: 10.1016/j.ajpc.2022.100392. eCollection 2022 Dec.
- Derived from this study: PubMed 36106308Khawaja T, Janus SE, Tashtish N, Janko M, Baeza C, Gilkeson R, Al-Kindi SG, Rajagopalan S. Prevalence of thoracic aortic aneurysm in patients referred for no/low-charge coronary artery calcium scoring: Insights from the CLARIFY registry. Am J Prev Cardiol. 2022 Aug 30;12:100378. doi: 10.1016/j.ajpc.2022.100378. eCollection 2022 Dec.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor, run by University Hospitals Cleveland Medical Center at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadeer Al-Kindi, M.D. (2168441000, sadeer.alkindi@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin Prescription (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075162, which also lists 6 linked publications.
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 26 Aug 2026.