NCT05098769

Brief Summary

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2021Dec 2026

Study Start

First participant enrolled

January 18, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

October 16, 2021

Last Update Submit

March 8, 2026

Conditions

Keywords

Pulmonary Embolism and ThrombosisDeterioration, Clinical

Outcome Measures

Primary Outcomes (1)

  • Adverse outcomes

    The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment.

    7 days and 30 days

Study Arms (1)

Acute pulmonary embolism

an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese

You may qualify if:

  • age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography

You may not qualify if:

  • pregnancy
  • reception of reperfusion treatment before admission
  • missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenjing Hospital of CHINA MEDICAL UNIVERSITY

Shenyang, Liaoning, China

RECRUITING

Related Publications (2)

  • Gao Y, Gu Z, Wei X, Wei S, Liu Y, Zhan S, Yang J, Qi C, Qi S, Wang M, Jia D. Ventricular septum curvature ratio: a novel imaging marker to predict clinical deterioration in normotensive acute pulmonary embolism. Crit Care. 2025 Oct 31;29(1):463. doi: 10.1186/s13054-025-05708-w.

  • Gao Y, Wei S, Liu Y, Yu Z, Zhan S, Yang B, Qi C, Qi S, Wang M, Jia D. Predicting Deterioration in Patients With Normotensive Acute Pulmonary Embolism Using Clinical-Imaging Features: A Multicenter Prospective Cohort Study. J Am Heart Assoc. 2025 Jul;14(13):e038984. doi: 10.1161/JAHA.124.038984. Epub 2025 Jun 27.

MeSH Terms

Conditions

Pulmonary EmbolismThrombosisClinical Deterioration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2021

First Posted

October 28, 2021

Study Start

January 18, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations