Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen(DPANDA) Study

Aortic Aneurysm Clinical Trial

Official title:

Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233087
• Other study ID #: DPANDA
• Status: Recruiting
• 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
• 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
• 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).

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Dissection

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.