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PET Stress Test vs CAC Scan for Coronary Artery Disease (ACCURATE Trial)

N/A

Recruiting

Led By Kirk U Knowlton, MD

Research Sponsored by Intermountain Health Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Disease history: 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)

Evidence of possible acute coronary syndrome based on an elevated troponin I ≥0.04ng/mL and/or acute ECG changes of ischemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the cost and effectiveness of two strategies for patients with possible coronary artery disease: a PET stress test or a CAC scan.

Who is the study for?

This trial is for men and women over 50 who may have coronary artery disease, as suggested by chest pain or similar symptoms. They must understand and agree to the study's process. People with known heart conditions, a high calcium score from previous tests, or certain other health issues can't join.

What is being tested?

The study compares two approaches in patients suspected of having coronary artery disease: one group gets a PET stress test directly while the other follows a 'calcium-first' strategy which could lead to medical management without PET if their calcium levels are low.

What are the potential side effects?

Potential side effects aren't specified here but generally, PET scans involve exposure to radiation and possible allergic reactions to contrast agents used during imaging. Medical management might include medications with various side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease, including severe valve issues or heart failure.

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I have signs of a possible heart attack shown by high troponin levels or ECG changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cost-effectiveness

Non-inferior major adverse cardiac endpoint (MACE) outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Management without stress-imagingExperimental Treatment1 Intervention

Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up.

Group II: Cardiac PET stress testing and test-dependent managementExperimental Treatment1 Intervention

Subjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not).

0 / 2Eligibility criteria met