Evaluating coronary artery disease using calcium scoring versus standard care

Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach

This study is testing if a simple calcium scan can help people over 50 with suspected coronary artery disease avoid more expensive tests and get better care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Intermountain Health Care, Inc. (other)
• Drugs / interventions: radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT03972774 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of a coronary artery calcium (CAC) first strategy to the usual care approach in assessing patients suspected of having coronary artery disease. It involves conducting a CAC scan, which is a cost-effective and low-radiation test, to identify the presence of coronary atherosclerosis. Patients who meet specific criteria, including being over 50 years old and having a CAC score of 1 or higher, will be included in the study. The goal is to determine if this approach can reduce the need for more expensive cardiac PET scans.

Who should consider this trial

Good fit: Ideal candidates are males or females aged 50 and older with suspected coronary artery disease and a CAC score of 1 or higher.

Not a fit: Patients with a history of known coronary artery disease or those who have previously had a CAC score greater than 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more cost-effective and accurate assessments of coronary artery disease, improving patient care.

How similar studies have performed: Previous studies have shown that using CAC scoring can effectively identify patients at risk for coronary artery disease, suggesting this approach has potential for success.

Eligibility criteria

Inclusion Criteria:

* Males or females ≥50 years old (i.e., to be of sufficiently high pre-test coronary risk)
* Cardiac PET regadenoson stress perfusion test has been ordered to assess a possible ischemic etiology of low/intermediate risk chest pain or equivalent symptoms (e.g., exertional dyspnea).
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
* CAC score of ≥1 per routine CAC first strategy (described above)

Exclusion Criteria:

1. Disease history: If available for any of the following diseases: prior known CAD, heart transplant, LVAD, untreated severe valve disease (i.e., severe mitral stenosis, severe mitral regurgitation, and/or severe aortic stenosis), or decompensated heart failure (DHF).
2. Those with a prior CAC score \>1.
3. CAC ≤1 prior to this current episode of cardiac assessment

   * Who ELECT to not receive an updated CAC evaluation OR their referring clinician specifically prefers cardiac PET.
   * CAC evaluation repeated at this current episode of cardiac assessment and is now \>1.
4. Evidence of possible acute coronary syndrome based on an elevated troponin I ≥0.04ng/mL and/or acute ECG changes of ischemia.
5. Life expectancy \<1 year, as assessed by the investigator(s)
6. Cardiac PET/CT is ordered in the pre-operative risk assessment in higher risk non-thoracic surgery.
7. Cardiac PET/CT is ordered for assessment of underlying ischemia in those with arrhythmia to guide anti-arrhythmic therapy.
8. Other conditions that in the opinion of the study investigators and/or referring clinician may increase risk to the subject and/or compromise the quality of the clinical trial.

Where this trial is running

Salt Lake City, Utah

• Intermountain Healthcare Hospitals and Clinics — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Kirk U Knowlton, MD — Intermountain Medical Center
• Study coordinator: Patti Spencer

Conditions: Coronary Artery Disease