Aortic AneurysmNCT03233087
Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen(DPANDA) Study
An observational study of Aortic Aneurysm and Aortic Dissection, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
The registry study aims to determine serial biomarkers to diagnosis and prognosis of aortic aneurysm/aortic dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2014to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: These cohorts consist of patients who was diagnosed as thoracic aortic aneurysm/dissection or initial suspicion of having thoracic aortic aneurysm/dissection.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan WANG, PhD, 86-010-64456169, wangyuan980510@163.com
Jie DU, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Top third of subjects based levels of selected biomarker. | Not described | |
| Middle third of subjects based levels of selected biomarker. | Not described | |
| Bottom third ofsubjects based levels of selected biomarker. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: These data is collected from the cases' medical record or during follow-up visit at 2-4 years after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Mar 2014
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Luhe Hospital, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Jilin University, First Affiliated Hospital, Sun Yat-Sen University, The General Hospital of Northern Theater Command, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233087
- Sponsor's protocol ID
- DPANDA
- Status last verified
- Jun 2024
- First submitted
- 26 Jul 2017
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Prognosis for Aortic Aneurysm aNd Dissection in Anzhen
- ClinicalTrials.gov ID
- NCT03233087
- Acronym / sponsor ID
- DPANDA
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Beijing Luhe Hospital, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Jilin University, First Affiliated Hospital, Sun Yat-Sen University, The General Hospital of Northern Theater Command, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- These cohorts consist of patients who was diagnosed as thoracic aortic aneurysm/dissection or initial suspicion of having thoracic aortic aneurysm/dissection.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortic Dissection, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, PhD (86-010-64456721, wangyuan980510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.