Clinical trial NCT02275143: Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis
Official title: Feasibility of Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis (CT TAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Keywords: Computed Tomography of Thorax, Abdomen and Pelvis
cancer patients
coronary angiogram evaluation
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having routine follow up cancer CT TAP scan

Brief summary: Currently patients with certain cancer usually have routine follow up (Computed Tomography of Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The study proposal allows the evaluation of the coronary arteries by modifying the current CT TAP technique without significant additional procedures, intravenous contrast or radiation - i.e. an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The question is does performing Computed Tomography (CT) of the thorax in such a way confer important additional information about cardiac risk? At the same time the investigators need to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate other structures in the chest. A recent small retrospective study has using a similar technique suggests that it may in fact improve image quality due to less cardiac related motion artefact.

Detailed description: The study is a non-inferiority observational study to primarily ensure that the Computed Tomography of Thorax, Abdomen and Pelvis (CT TAP) technique produces equivalent image quality of the lungs (hence the need to scan with both conventional technique and the Electrocardiograph \[ECG\] gated technique) and secondarily to evaluate the effectiveness of demonstrating the coronary arteries in this cohort of patients who have not received heart rate control.

Eligibility criteria: Inclusion Criteria:

* Patients having routine follow up cancer CT TAP scan
* Age more than or equal to 40 years of age at the time of scan.
* Able to provide informed written consent
* Able to hold their breath for at least 10 seconds
* Has regular heart rate
* Able to follow verbal commands for breath holding and remain still for the duration of scanning
* Able to lie supine for the entirety of the scan

Exclusion Criteria:

* Patient unable to give informed consent.
* Patients unable to lie supine
* Patient not able to breath hold for at least 10 seconds.
* Patients not having regular heart rate. Patient with atrial fibrillation or \>2 atrial or ventricular premature beats on a preoperative 12 lead ECG (suboptimal image quality results from irregular heart rhythms)
* Patient having eGFR \<30, to avoid risk of contrast nephrotoxicity in patients potentially at risk) or chronic renal failure on dialysis
* Patient has known contrast reaction.
* Patient is pregnant.
* Patients BMI\>35
* Unavailability of research slot to accommodate for the urgency of the scan requested.

Primary outcomes:
measure: Objective Image quality analysis
timeFrame: 20 minutes
measure: Objective Image quality analysis
timeFrame: 20 minutes
measure: Subjective Image quality analysis
timeFrame: 20 minutes
Secondary outcomes:
measure: Dose estimation
timeFrame: 20 minutes
measure: Coronary segments analysis
timeFrame: 20minutes
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust (PHNT)
state: Devon
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: Carl Roobottom, MBChB FRCP
role: STUDY_DIRECTOR
References: