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

Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT03233087
Collaborator
Beijing Luhe Hospital (Other), The First Affiliated Hospital of Dalian Medical University (Other), The First Hospital of Jilin University (Other)
1,500
1
106
14.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen
    Actual Study Start Date :
    Mar 1, 2014
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Dignosis of each participant [These data is collected from the cases' medical record in an average of 6 month after the sample recruiting]

      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.

    2. Prognosis of each participant [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Anzhen Hospital Beijing Beijing China 100029

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Institute of Heart, Lung and Blood Vessel Diseases
    ClinicalTrials.gov Identifier:
    NCT03233087
    Other Study ID Numbers:
    • DPANDA
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2020