Coarctation of AortaNCT04011956
Prognosis and Integrative Assessment of Aortic Coarctation Patients in China
An observational study of Coarctation of Aorta, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Coarctation of Aorta
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.
Who may be able to join
- Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
- Patients who can cooperation with study procedures.
Who cannot join
- Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
- History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yuan WANG, PhD, 86-010-64456169, wangyuan980510@163.com
Yan GU, PhD, 86-010-64456874, echoguyan@163.com
About this study
Official title: Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.
Read the detailed description
The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.
- Conditions
- Coarctation of Aorta
- Medical subject headings
- Aortic Coarctation
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 |
|---|---|---|
| Retrospective Cohort of Aortic Coarctation | Patients diagnosed as aortic coarctation and undergone corrected procedures from 2002 to Feb 28th 2019 were recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. | |
| Perspective Cohort of Aortic Coarctation | Patients diagnosed as aortic coarctation and undergone corrected procedures after Mar. 1st 2019 will be recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass
Left ventricular mass will be measured by 2D echocardiography. For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Measured: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Hypertension
Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary outcomes (10)
Left ventricular systolic function
Left ventricular systolic function assessed by echocardiography
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular diastolic function
Left ventricular diastolic function assessed by echocardiography (TDI)
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular systolic heart function of longitudinal myocardium
Left ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler).
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Exercise tolerance
Six minutes walking distance will be recorded and analyzed to evaluate the exercise tolerance. Echocardiographic images will be obtained after six minutes walking to assess the reserve function of left ventricle. Blood pressure will also be taken immediately after the Six minutes walking to analyze exercise-induced hypertension.
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Biomarkers of vascular inflammation
Biomarkers of inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Measured: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of left ventricle remodeling
Biomarkers of left ventricle remodeling (ST2)
Measured: For the retrospective cohort, follow-up visit of 1 month to 20 years after primary treatment. For the prospective cohort, the data is collected prior to primary treatment and during follow-up visit of one year after primary treatment
Biomarkers of left heart function
Biomarkers of left heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Measured: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of hypertension phenotype related to aortic coarctation
Biomarkers of hypertension phenotype related to aortic coarctation
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Recoarctation
Recoarctation assessed by echocardiography or computed tomography angiography.
Measured: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
All-cause death
The data is collected during follow-up visit at follow-up time point.
Measured: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of AortaStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Bayi Children's Hospital Affiliated to PLA Army General Hospital, China, Capital Institute of Pediatrics, China
- Responsible party
- Sponsor
- Investigators
- Jie DU, PhD, Principal investigator, Beijing Institute of Heart, Lung and Blood Vessel Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011956
- Sponsor's protocol ID
- PICC
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2019
- Last updated
- 14 Jul 2020
- 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 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA
- ClinicalTrials.gov ID
- NCT04011956
- Acronym / sponsor ID
- PICC
- Conditions
- Coarctation of Aorta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Bayi Children's Hospital Affiliated to PLA Army General Hospital, China, Capital Institute of Pediatrics, China
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 2019 (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.
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.
Detailed description
The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort of Aortic Coarctation | – | –Patients diagnosed as aortic coarctation and undergone corrected procedures from 2002 to Feb 28th 2019 were recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
| Perspective Cohort of Aortic Coarctation | – | –Patients diagnosed as aortic coarctation and undergone corrected procedures after Mar. 1st 2019 will be recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.
Key inclusion criteria (2 listed)
- Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
- Patients who can cooperation with study procedures.
Key exclusion criteria (2 listed)
- Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
- History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
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
Change in left ventricular mass
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Left ventricular mass will be measured by 2D echocardiography. For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.
Hypertension
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.
10 secondary outcomes
Left ventricular systolic function
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular diastolic function
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Left ventricular systolic heart function of longitudinal myocardium
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Exercise tolerance
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Biomarkers of vascular inflammation
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of left ventricle remodeling
Time frame: For the retrospective cohort, follow-up visit of 1 month to 20 years after primary treatment. For the prospective cohort, the data is collected prior to primary treatment and during follow-up visit of one year after primary treatment
Biomarkers of left heart function
Time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Biomarkers of hypertension phenotype related to aortic coarctation
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Recoarctation
Time frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
All-cause death
Time frame: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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. This study is not recruiting at the moment.
Jie DU, PhD principal investigator
Beijing Institute of Heart, Lung and Blood Vessel Diseases
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 Coarctation of Aorta, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan WANG, PhD (86-010-64456169, wangyuan980510@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass (time frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)). 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 14 Jul 2020.