Trial Outcomes & Findings for CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients (NCT NCT03083093)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

1 year

Results posted on

2021-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	CTEPH Patients the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE	Non CTEPH Patients the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CTEPH Patients n=50 Participants the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE	Non CTEPH Patients n=50 Participants the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded	Total n=100 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 15 • n=50 Participants	56 years STANDARD_DEVIATION 15 • n=50 Participants	58 years STANDARD_DEVIATION 17 • n=100 Participants
Sex: Female, Male Female	27 Participants n=50 Participants	33 Participants n=50 Participants	60 Participants n=100 Participants
Sex: Female, Male Male	23 Participants n=50 Participants	17 Participants n=50 Participants	40 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CTEPH Patients n=50 Participants the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE	Non CTEPH Patients n=50 Participants the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.	70 Sensitivity Interval 55.0 to 82.0	70 Sensitivity Interval 55.0 to 82.0

Adverse Events

CTEPH Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non CTEPH Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

F.A. Klok, MD PhD

LUMC

Phone: 003171 526 9111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place