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

Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen

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

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm; Aortic Dissection

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Yuan Wang, PhD; Phone Number: 86-010-64456721; Email: wangyuan980510@163.com
• Study Contact Backup: Name: Xue Wang, MD; Phone Number: +86 010-64456721; Email: snowlove_@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Collaborators: The First Hospital of Jilin University; The First Affiliated Hospital of Dalian Medical University; Beijing Luhe Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm
• Other Study ID Numbers: DPANDA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No