Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2018-12-31

Brief Summary

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Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

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Detailed Description

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Cardiac computed tomography (CT) scan is an ideal diagnostic tool for identifying coronary artery disease in patients with low or intermediate risk. In recent years, cardiac CT is being often performed in patients who are at high risk either for coronary artery disease or lung cancer. The update edition of the National Institute for Health and Care Excellence (NICE) guidelines recommends cardiac CT as the first-line diagnostic tool for patients with new-onset chest pain due to suspected coronary artery disease. Also, symptomatic patients with known coronary artery disease and previous percutaneous coronary intervention who have an unclear stress test but whose presentation suggests a high likelihood of having an in-stent restenosis or a 'de novo' stenosis might benefit from cardiac CT. In 2014, the U.S. Preventive Services Task Force recommended annual lung cancer screening with ultra-low dose computed tomography for current and former heavy smokers aged 55 to 80 years. Indeed, lung cancer screening in patients with suspected or known coronary artery disease undergoing cardiac CT may provide the opportunity to implement recommendation for lung cancer screening in clinical practice.This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Conditions

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HEAVY SMOKING

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of both coronary arteries and thoracic area for simultaneous coronary artery and lung cancer screening

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lung and coronary CT assessment

Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area

Group Type ACTIVE_COMPARATOR

Lung and coronary CT assessment

Intervention Type DIAGNOSTIC_TEST

Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

Coronary CT assessment

Subjects will undergo CT assessment of coronary arteries only

Group Type ACTIVE_COMPARATOR

Coronary CT assessment

Intervention Type DIAGNOSTIC_TEST

Subjects will undergo coronary arteries CT assessment only

Interventions

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Lung and coronary CT assessment

Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

Intervention Type DIAGNOSTIC_TEST

Coronary CT assessment

Subjects will undergo coronary arteries CT assessment only

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Symptomatic subjects with effort-induced or typical chest pain
* High probability of coronary artery disease
* Known coronary artery disease
* Willing to participate to the study
* Informed consent to undergo CT scan