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Procedure

UHR-CT vs Conventional CT for Coronary Heart Disease

N/A

Recruiting

Led By Joao Lima, Professor

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Patients aged 21-85 years

Be older than 18 years old

Must not have

History of multiple myeloma or previous organ transplantation

Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare UHR-CT and conventional resolution CT for diagnosis of coronary heart disease. UHR-CT has higher radiation exposure and longer scan times, so it's important to study if it's worth using.

Who is the study for?

This trial is for individuals with various forms of heart disease, including coronary artery disease and myocardial ischemia. Participants should be generally at lower risk to assess the effectiveness of a new Ultra High-Resolution CT scan compared to conventional CT scans.

What is being tested?

The CORE-COMPARE study is testing whether an advanced scanning technology called Ultra High-Resolution Computed Tomography (UHR-CT) can better identify blockages in the heart's arteries than standard CT scans without exposing patients to additional scans.

What are the potential side effects?

Potential side effects may include exposure to higher levels of radiation than conventional CT scans, which could increase cancer risk over time. Longer scan times might also cause discomfort or inconvenience for some patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 85 years old.

Exclusion Criteria

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

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I have had multiple myeloma or an organ transplant.

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My kidney function is reduced, with high creatinine or low clearance.

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I have had a procedure to open blocked arteries or a bypass surgery.

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I might be having a heart attack.

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I have been diagnosed with moderate or severe narrowing of my heart's aortic valve.

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I have severe heart failure symptoms.

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I have an irregular heartbeat or a severe heart block.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard.

Secondary study objectives

Assessment of vascular and plaque metrics

Diagnostic Confidence Assessment

Interobserver Variability Analysis

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