Coronary Artery DiseasePROSPECTNCT06001073
Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics
An observational study of Coronary Artery Disease and Arrhythmias, Cardiac, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research… Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases
- How many people
- 25,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2022to 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cardiovascular and cerebrovascular diseases will be recruited, including coronary artery disease, arrhythmia, heart valve disease, aortic dissection, cardiac masses, myocarditis, hypertension, cardiomyopathy, structural heart disease, ischemic cerebrovascular disease, hemorrhagic cerebrovascular disease, and intracranial space occupying lesion.
Who may be able to join
- Patients who are regularly visited and followed up in the appropriate patient; department.
- All patients met at least one of the following diagnostic criteria for cardiovascular and cerebrovascular diseases:
- coronary artery disease group;
- arrhythmia group;
- heart valve disease group;
- aortic dissection group;
Show all 14Show fewer
- cardiac masses group;
- myocarditis group;
- hypertension group;
- cardiomyopathy group;
- structural heart disease group;
- ischemic cerebrovascular disease group;
- hemorrhagic cerebrovascular disease group;
- intracranial space occupying lesion group.
Who cannot join
- Age <3 years or >80 years old;
- Pregnant and lactating women;
- The patient declined to provide informed consent to participate in the study;
- None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
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
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, liguoliang_med@163.com
About this study
Official title: Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study
The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.
Read the detailed description
Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension, etc. It is one of the major public health problems in the world. The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.
- Conditions
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases, Aortic Dissection, Heart Neoplasms, Myocarditis
- Being tested
- Observational; No Interventions were given.
- Keywords
- Cardiovascular diseases, Cerebrovascular diseases, Prognosis, Multi-omics
- Medical subject headings
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases, Aortic Dissection, Heart Neoplasms, Myocarditis, Hypertension, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational; No Interventions were given.Other
Observational; No Interventions were given.
| Study group | Role | What they receive |
|---|---|---|
| Coronary artery disease group | Diagnosis of coronary artery disease by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Arrhythmia group | Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Heart valve disease group | Diagnosis of heart valve disease by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| aortic dissection group | Diagnosis of aortic dissection by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Cardiac masses group | Diagnosis of cardiac messes by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Myocarditis group | Diagnosis of myocarditis by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Hypertension group | Diagnosis of hypertension by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Cardiomyopathy group | Diagnosis of cardiomyopathy by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Structural heart disease group | Diagnosis of structural heart disease by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Ischemic cerebrovascular disease group | Diagnosis of ischemic cerebrovascular disease by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Hemorrhagic cerebrovascular disease group | Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines. Receives: Other: Observational; No Interventions were given. | |
| Intracranial space occupying lesion group | Diagnosis of intracranial space occupying by clinical guidelines. Receives: Other: Observational; No Interventions were given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MACCE
Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.
Measured: Through study completion, up to 5 years.
Secondary outcomes (4)
Change of all-cause mortality
Incidence of patients' death from any cause.
Measured: Through study completion, up to 5 years.
Incidence of myocardial infarction
Changes of serum myocardial zymogram level and ECG were used for diagnosing of myocardial infarction.
Measured: Through study completion, up to 5 years.
Incidence of coronary revascularization.
Incidence of percutaneous coronary intervention or coronary artery bypass grafting.
Measured: Through study completion, up to 5 years.
Incidence of stroke
Stroke were assessed by radiologist using CT scan or other imaging test.
Measured: Through study completion, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Dec 2022
- Primary completion30 Jun 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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- 25,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Gaoxin Hospital, First Affiliated Hospital of Chongqing Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor
- Investigators
- Gouliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityYang Yan, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001073
- Sponsor's protocol ID
- XJTU1AF2023LSK-353
- Acronym
- PROSPECT
- Status last verified
- Mar 2024
- First submitted
- 14 Aug 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06001073
- Acronym / sponsor ID
- PROSPECT / XJTU1AF2023LSK-353
- Conditions
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases, Aortic Dissection, Heart Neoplasms, Myocarditis
- Keywords
- Cardiovascular diseases, Cerebrovascular diseases, Prognosis, Multi-omics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an Gaoxin Hospital, First Affiliated Hospital of Chongqing Medical University, General Hospital of Ningxia Medical University, Second Affiliated Hospital of Nanchang University
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 2023 (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 etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.
Detailed description
Cardiovascular and cerebrovascular diseases refer to ischemic and hemorrhagic diseases of the heart, brain and body tissues caused by hyperlipidemia, blood viscosity, atherosclerosis, hypertension, etc. It is one of the major public health problems in the world. The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Coronary artery disease group | – | Other: Observational; No Interventions were given.Diagnosis of coronary artery disease by clinical guidelines. |
| Arrhythmia group | – | Other: Observational; No Interventions were given.Diagnosis of arrhythmia by clinical guidelines. by clinical guidelines. |
| Heart valve disease group | – | Other: Observational; No Interventions were given.Diagnosis of heart valve disease by clinical guidelines. |
| aortic dissection group | – | Other: Observational; No Interventions were given.Diagnosis of aortic dissection by clinical guidelines. |
| Cardiac masses group | – | Other: Observational; No Interventions were given.Diagnosis of cardiac messes by clinical guidelines. |
| Myocarditis group | – | Other: Observational; No Interventions were given.Diagnosis of myocarditis by clinical guidelines. |
| Hypertension group | – | Other: Observational; No Interventions were given.Diagnosis of hypertension by clinical guidelines. |
| Cardiomyopathy group | – | Other: Observational; No Interventions were given.Diagnosis of cardiomyopathy by clinical guidelines. |
| Structural heart disease group | – | Other: Observational; No Interventions were given.Diagnosis of structural heart disease by clinical guidelines. |
| Ischemic cerebrovascular disease group | – | Other: Observational; No Interventions were given.Diagnosis of ischemic cerebrovascular disease by clinical guidelines. |
| Hemorrhagic cerebrovascular disease group | – | Other: Observational; No Interventions were given.Diagnosis of hemorrhagic cerebrovascular disease by clinical guidelines. |
| Intracranial space occupying lesion group | – | Other: Observational; No Interventions were given.Diagnosis of intracranial space occupying by clinical guidelines. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cardiovascular and cerebrovascular diseases will be recruited, including coronary artery disease, arrhythmia, heart valve disease, aortic dissection, cardiac masses, myocarditis, hypertension, cardiomyopathy, structural heart disease, ischemic cerebrovascular disease, hemorrhagic cerebrovascular disease, and intracranial space occupying lesion.
Key inclusion criteria (14 listed)
- Patients who are regularly visited and followed up in the appropriate patient; department.
- All patients met at least one of the following diagnostic criteria for cardiovascular and cerebrovascular diseases:
- coronary artery disease group;
- arrhythmia group;
- heart valve disease group;
Key exclusion criteria (4 listed)
- Age <3 years or >80 years old;
- Pregnant and lactating women;
- The patient declined to provide informed consent to participate in the study;
- None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational; No Interventions were given.Observational; No Interventions were given. | Other | Arrhythmia group, Cardiac masses group, Cardiomyopathy group, Coronary artery disease group, Heart valve disease group, Hemorrhagic cerebrovascular disease group, Hypertension group, Intracranial space occupying lesion group, Ischemic cerebrovascular disease group, Myocarditis group, Structural heart disease group, aortic dissection group |
Primary outcome
Change of MACCE
Time frame: Through study completion, up to 5 years.
Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.
4 secondary outcomes
Change of all-cause mortality
Time frame: Through study completion, up to 5 years.
Incidence of myocardial infarction
Time frame: Through study completion, up to 5 years.
Incidence of coronary revascularization.
Time frame: Through study completion, up to 5 years.
Incidence of stroke
Time frame: Through study completion, up to 5 years.
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 12 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Gouliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Yang Yan principal investigator
First Affiliated Hospital of Xian Jiaotong University
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 Coronary Artery Disease and Arrhythmias, Cardiac, run by First Affiliated Hospital Xi'an Jiaotong University 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 14 inclusion and 4 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 12 Jul 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 Gouliang Li (13759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MACCE (time frame: Through study completion, up to 5 years.). 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 12 Jul 2024.