CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled / 115 target
Drug / intervention
Color Doppler Ultrasoundother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05413317
NCT05413317N/ACompletedHigh Momentum (2.2/mo)Completion was 31mo ago

Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer·observational·Posted Jun 10, 2022·Updated Jun 12, 2026

In Brief

An observational study evaluating Color Doppler Ultrasound for Pulmonary Embolism. Completed, enrolled 115 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Venous thromboembolic disease is a clinical entity including pulmonary embolism (PE) and deep vein thrombosis (DVT). It is a chronic disease with 30% recurrence rate at 10 years. In patients with recurrent PE clinical suspicion, an objective and accurate diagnostic method/strategy is warranted to exclude or confirm a PE new episode diagnosis and to decide on treatment initiation. Recurrent PE diagnosis raises several issues related to the limitations of clinical scores, D-dimer testing, and diagnostic imaging used for a first episode diagnosis. Most importantly, residual obstruction on chest imaging reported in more than 50% of cases at 6 months can make it difficult to distinguish between an old and a new thrombosis in the absence of possible comparison with a previous imaging carried out under the same modalities. There are currently few recommendations about the diagnostic strategy for patients with a recurrent PE clinical suspicion and these recommendations are not very consistent due to the lack of a validated strategy. None of current guidelines have included imaging-detectable lower-limb DVT within the strategies despite a reported high prevalence of PE-associated DVT. In one study using venography, 82% (95% CI 76.5 - 86.9) of angiographically-proven PE patients had an associated proximal or distal deep vein thrombosis, of which 42% were asymptomatic. In another study using lower-limb venous ultrasound, a proximal or distal DVT was detected in 93% (95% CI 85-97) of patients with PE.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 10, 2022
Enrollment StartMar 4, 2022
Primary CompletionNov 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.1 years ago

Arms & Interventions

Adult patients hospitalized for suspicion of pulmonary embolism recurrenceother

Patients with at least one of the following symptoms: acute dyspnea or aggravation of chronic dyspnea, chest pain, hemoptysis or syncope

Other: Color Doppler Ultrasound

Interventions

Color Doppler Ultrasoundother

Comparison with conventional diagnosis strategy including a clinical probability score, D-dimers and chest imaging.