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NCT03083093: InShapeIII

CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients

Completed Results posted Last updated 19 April 2021
What this trial tests

trial testing The initial CTPA will be reviewed in CTEPH in 100 participants. Completed in 1 March 2018.

Timeline
1 May 2017
Primary endpoint
1 March 2018
1 March 2018

Quick facts

Lead sponsorLeiden University Medical Center
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date1 May 2017
Primary completion1 March 2018
Estimated completion1 March 2018
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with CTEPH or Pulmonary Embolism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE. Primary · 1 year

The sensitivity of CTPA is determined by calculating the proportion of scans that are read as "positive for the CTEPH specific radiological pattern" in patients with confirmed CTEPH and the specificity is determined by calculating the proportion of scans that are read as "negative for the CTEPH specific radiological pattern" in patients without CTEPH.

GroupValue95% CI
CTEPH Patients7055 – 82
Non CTEPH Patients7055 – 82

Sponsor's own description

In this study the investigators will evaluate whether more careful reading (than the current standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute PE from those with more chronic or acute on chronic PE, which could be indicative of the presence of chronic thromboembolic pulmonary hypertension (CTEPH)"

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for CTEPH

Currently open trials in the same condition.

Other Leiden University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03083093.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing