An interventional study of Ddimer testing in Syncope, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope
Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope
201 studies on the registry are indexed under Syncope; 36 are open to participants now.
This study's enrollment of 459 is above the median of 100 across 108 interventional studies indexed under Syncope.
Browse Syncope studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Included patients will undergo a formal work up for pulmonary embolism: Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan.
Biological: Ddimer testing
Included patients will undergo a formal work up for pulmonary embolism: Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan.
diagnosis of Pulmonary embolism within 72 hrs after ED visit Safety
diagnosis of Pulmonary embolism within 72 hrs after ED visit ( Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan).
Time frame: 72 hours after ED visit
Validation of usual clinical decision rules-Wells
Wells score: Clinical signs and symptoms of DVT 3 Immobilization or surgery within 4 weeks 1.5 Heart rate \> 100 beats per min 1.5 Previous DVT or PE 1.5 Hemoptysis 1 Malignancy 1 Alternative diagnosis is less likely than PE 3 Low: 0-1; intermediate: 2-6; high: \>6
Time frame: Day 0
Validation of usual clinical decision rules-Revised Geneva Score
Age \> 65 years 1 Previous DVT or PE 3 Surgery or fracture within 1 monht 2 Active malignant condition within a year 2 Unilateral lower limb pain 3 Hemoptysis 2 Heart Rate 75 - 94 beats per min 3 \>94 beats per min 5 Pain on lower limb deep venous palpation and unilateral edema 5 low: 0-3; intermediate: 4-10; high: \>11
Time frame: Day 0
Validation of usual clinical decision rules-PERC
PERC: * Age less than 50 years * Heart rate less than 100 beats per minute * No prior history of thrombo-embolic event * Oxygen saturation greater than 94% * No trauma or surgery in the past four weeks * No hemoptysis * No exogenous estrogen intake * No unilateral leg swelling
Time frame: Day 0
Prevalence of Pulmonary Embolism among patients with cancer history.
Time frame: Day 28
rate of false positive of the PERC rule
Patients with a PERC=0 ultimately diagnosed with a pulmonary embolism within 72 hours
Time frame: 72 hours after ED visit
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Dec 2018, 6 months.
Of 39 non-industry interventional studies with no phase under Syncope, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 6 months is below that.
Counting every sponsor, half of 48 studies reached it within 28 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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