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Clinical Trials/NCT03233087
NCT03233087
Recruiting
Not Applicable

Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen

Beijing Institute of Heart, Lung and Blood Vessel Diseases1 site in 1 country1,500 target enrollmentMarch 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Aneurysm
Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Enrollment
1500
Locations
1
Primary Endpoint
Prognosis of each participant
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
December 31, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Prognosis of each participant

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

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

Dignosis of each participant

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

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.

Study Sites (1)

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