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NCT Number: NCT03233087

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

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

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Key information

Conditions

Aortic Aneurysm Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Jie DU, PhD

PRINCIPAL_INVESTIGATOR

Yuan WANG, PhD

CONTACT

[email protected]

86-010-64456169

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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

    • 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xue Wang, MD

CONTACT

[email protected]

+86 010-64456721

Yuan Wang, PhD

CONTACT

[email protected]

86-010-64456721

Sponsors and collaborators

Lead sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Other

Collaborators

  • Beijing Luhe Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Dalian Medical University
  • The First Hospital of Jilin University
  • The General Hospital of Northern Theater Command

Registry information

Official study title

Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2017
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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