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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03806907 |
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Date of registration:
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15/01/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Iodine Subtraction Mapping in the Diagnosis of Chronic Pulmonary Thromboembolic Disease
INSPIRE |
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Scientific title:
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IodiNe Subtraction maPpIng in the Diagnosis of chRonic Pulmonary thromboEmbolic Disease (INSPIRE): An Observational Diagnostic Study |
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Date of first enrolment:
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April 1, 2019 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03806907 |
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Study type:
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Observational |
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Study design:
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Phase:
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Contacts
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Name:
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Andy J Swift, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sheffield |
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Name:
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Yousef Shahin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sheffield |
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Name:
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Andy J Swift, PhD |
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Address:
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Telephone:
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0114 2159595 |
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Email:
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a.j.swift@sheffield.ac.uk |
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Affiliation:
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Name:
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David Kiely, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheffield Teaching Hospitals NHS Foundation Trust |
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Name:
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Kavitasagary Karunasaagarar |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheffield Teaching Hospitals NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients suspected to have CTED and require a SPECT and CTPA
Exclusion Criteria:
- Less than 18 years old
- Unable to provide informed consent
- Significant renal dysfunction (GFR <30ml/min)
- History of hypersensitivity to contrast material
- Pregnancy
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Thromboembolic Pulmonary Hypertension
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Intervention(s)
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Radiation: Computed tomography lung subtraction iodine mapping
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Primary Outcome(s)
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Assessment of the diagnostic performance of CT-LSIM for evaluation of pulmonary perfusion in patients with known or suspected chronic thromboembolic pulmonary hypertension (CTEPH)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Diagnostic accuracy of CT-LSIM compared with single photon emission computed tomography (SPECT)
[Time Frame: 12 months]
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Number of alternate diagnoses made on CT-LSIM over lung SPECT imaging
[Time Frame: 12 months]
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Diagnostic accuracy of CT-LSIM compared with CT pulmonary angiography (CTPA)
[Time Frame: 12 months]
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Diagnostic accuracy of experienced and less experienced observers
[Time Frame: 12 months]
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Radiation dose between CT-LSIM, SPECT and CTPA
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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