NCT03233087

Brief Summary

The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic aneurysm/aortic dissection.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Mar 2014

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 Progress82%
Mar 2014Dec 2028

Study Start

First participant enrolled

March 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

14.8 years

First QC Date

July 26, 2017

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Dignosis of each participant

    1. Patients with Aneurysm/Dissection had image information from ultrasound cardiograms and computed tomography to confirm the final diagnosis. 2. AMI if they had chest pain lasting \>20 min, diagnostic serial ECG changes comprising new pathological Q waves or ST-segment and T-wave changes, and a plasma creatine kinase-MB elevation greater than twice the normal level or cardiac troponin I (cTnI) level greater than 0.1 ng/mL. 3. Diagnosis of PE was confirmed by positive spiral computed tomography or pulmonary angiography, a high probability on ventilation perfusion scintigraphy, or a proximal deep vein thrombosis documented on compression ultrasonography or angiography.

    These data is collected from the cases' medical record in an average of 6 month after the sample recruiting

  • Prognosis of each participant

    Prognosis information including all-cause mortality and in-hospital mortality.

    These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.

Study Arms (3)

Top third of subjects based levels of selected biomarker.

Middle third of subjects based levels of selected biomarker.

Bottom third ofsubjects based levels of selected biomarker.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

These cohorts consist of patients who was diagnosed as thoracic aortic aneurysm/dissection or initial suspicion of having thoracic aortic aneurysm/dissection.

You may qualify if:

  • Retrospective
  • All patients who were referred to the surgical service for evaluation and management of aortic dissection were included.
  • Perspective
  • Patients with initial suspicion of having AAD were perspectively enrolled.

You may not qualify if:

  • Retrospective
  • Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;
  • Patients with aortic trauma, pseudo aneurysm, history of heart failure, renal dysfunction, severe pulmonary diseases, or active cancer;
  • Patients who entered the hospital for checkups after surgery.
  • Perspective
  • Patients in whom there is little or no suspicion of a life-threatening disease;
  • Patients with confirmed acute myocardial infarction,angina or pulmonary embolism
  • The symptoms were clearly not related to AD (e.g. pleurisy, pneumonia, acute abdominal diseases).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Aortic AneurysmAortic Dissection

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

March 1, 2014

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations