Clinical trial NCT03233087: Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen(DPANDA) Study
Official title: Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm
Aortic Dissection
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Beijing Luhe Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: The First Hospital of Jilin University
name: First Affiliated Hospital, Sun Yat-Sen University
name: The General Hospital of Northern Theater Command
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2017-07-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: The registry study aims to determine serial biomarkers to diagnosis and prognosis of 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Dignosis of each participant
timeFrame: These data is collected from the cases' medical record in an average of 6 month after the sample recruiting
measure: Prognosis of each participant
timeFrame: These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
References: