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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03233087
Other study ID # DPANDA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2014
Est. completion date December 31, 2022

Study information

Verified date December 2020
Source Beijing Institute of Heart, Lung and Blood Vessel Diseases
Contact Yuan Wang, PhD
Phone 86-010-64456721
Email wangyuan980510@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

The study aims to investigate the role of candidate biomarkers in the diagnosis and prognosis of AA and AD. In the diagnosis part, we begin with a discovery phase where individually matched case-control study. Patients within each disease outcomes (i.e. AD, AMI, PE, AA without AD and healthy controls) are age and sex matched and retrospectively included.In the prognosis part of the study, patients with confirmed AA and AD are enrolled. The primary outcome is the all-cause mortality based on the death certificates. The secondary outcome is the in-hospital mortality according to the patients'medical records.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 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).

Study Design


Locations

Country Name City State
China Beijing Anzhen Hospital Beijing Beijing

Sponsors (4)

Lead Sponsor Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases Beijing Luhe Hospital, First Hospital of Jilin University, The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dignosis of each participant Patients with Aneurysm/Dissection had image information from ultrasound cardiograms and computed tomography to confirm the final diagnosis.
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.
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
Primary 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.
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