Risk Factor, Cardiovascular, Young CHD PatientsNCT03040869
Risk Facotors in Young CHD Patients
An observational study of Risk Factor, Cardiovascular, Young CHD Patients, run by Shanghai Zhongshan Hospital.
Trial summary
Coronary heart disease (CHD) is the leading global cause of human death. Over the past decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the progression of clinical research and development of technical means and the mortality of CHD has decreased by nearly 50% in western… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Risk Factor, Cardiovascular, Young CHD Patients
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2017to 31 Jul 2020
- How long will I take part?
- 3 Months
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: ①Below or equal to 45 years of age; ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan;
Who may be able to join
- ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan
Who cannot join
- Patients who suffered serious liver and kidney diseases, infections, severe systemic disease such as blood disease and malignant tumor; ②Pregnancy or breast-feeding women; ③Patients who could not timely follow up or refuse to participate in this study.
About this study
Official title: Risk Factors Investigation in Young Patients With Coronary Artery Disease and Their Clinical Follow-up
Coronary heart disease (CHD) is the leading global cause of human death. Over the past decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the progression of clinical research and development of technical means and the mortality of CHD has decreased by nearly 50% in western countries [1]. However, there are surveys shows that with the improvement of living standards and changes in lifestyle, the incidence of CHD is still rising in China and other developing countries, and the prevalence trend is obvious younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less than or equal to 45 years. Compared with other age-group CHD, young CHD has the following characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two extremes often exists in coronary lesions: mild or no atherosclerosis and severe triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in the same site repeated after interventional treatment, rapid progress of lesion in non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or bypass surgery, but the rate of revascularization is significantly higher in following 10 years.
Read the detailed description
Study method
- Recruited the patients meet the inclusion criteria since March 2016, collected the information of the change of risk factors, angina in pre-operation, mode of onset, characteristics of coronary artery, morbility of treatment,clinical follow-up; ② Collect the following information in clinical cases: gender, age, history of hypertension, history of diabetes, cholesterol level, triglyceride level, sedentary, body index, family history of CHD, genotype of ALDH2 and MTHFR, history of myocardial infarction, coronary artery lesions and operation situation; ③ The follow-up was performed through clinic and telephone every half or one year. The details include whether recurrence of angina, the main symptom, the cause of attack, lasting time, the efficacy of taking nitroglycerin, whether performed electrocardiography examination, whether occurred myocardial infarction and the attack site. whether performed interventional therapy and CABG surgery again and the cause of surgery, whether re-examined coronary arteriongraphy, whether death and the cause, and the occurred date in above events; ④ Analysis the pathogenic intensity with each risk factors with other age group CHD.
3.2 Study population 3.2.1 inclusion criteria
Young CHD group:
- Below or equal to 45 years of age; ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan; ③ Signed informed consent form. Non-young CHD group
- Below or equal to 45 years of age; ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by Coronary angiography or coronary CT scan; ③ Risk factors such as the gender, high cholesterol, high blood pressure, overweight, diabetes, smoking, homocysteine levels matched with inclusion criteria 1 subjects enrolled. ④ Signed informed consent form Young non-coronary heart disease
- Below or equal to 45 years of age; ② Patients were confirmed to rule out the stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by Coronary angiography or coronary CT scan; ③ Signed Informed consent form. 3.2.2 Exclusion criteria Exclusion criteria in each group are as follows
- Patients who suffered serious liver and kidney diseases, infections, severe systemic disease such as blood disease and malignant tumor; ② Pregnancy or breast-feeding women;
- Patients who could not timely follow up or refuse to participate in this study. 3.2.3 Exit criteria Subjects were claimed to withdraw informed consent. 3.3 Grouping method and cases number
- Experimental group：1250 samples
- Positive control group：1250 samples ③ Negative control group：500 samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| CHD Patients | coronary angioplasty confirmed coronary heart disease. | |
| non-CHD patients | coronary angioplasty confirmed no coronary heart disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart failure
LVEF less than 40%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factor, Cardiovascular, Young CHD PatientsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Lei, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040869
- Sponsor's protocol ID
- 2016-02-25-1
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: laboratory test
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Investigation in Young Patients With Coronary Artery Disease and Their Clinical Follow-up
- ClinicalTrials.gov ID
- NCT03040869
- Acronym / sponsor ID
- 2016-02-25-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- 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.
Coronary heart disease (CHD) is the leading global cause of human death. Over the past decade, level of overall diagnosis and treatment of CHD has been greatly improved due to the progression of clinical research and development of technical means and the mortality of CHD has decreased by nearly 50% in western countries [1]. However, there are surveys shows that with the improvement of living standards and changes in lifestyle, the incidence of CHD is still rising in China and other developing countries, and the prevalence trend is obvious younger [2]. The so-called young CHD, generally refers to the age at onset of CHD is less than or equal to 45 years. Compared with other age-group CHD, young CHD has the following characteristics: 1. Genetic factors have a stronger effect at younger onset ages, and incidence with obvious familial aggregation[3]; 2 Often with the onset of acute coronary syndrome, presumably may be associated with strong inflammation of the lesion; 3. Two extremes often exists in coronary lesions: mild or no atherosclerosis and severe triple-vessel disease; 4 Rapid progression of atherosclerotic lesions, stent restenosis in the same site repeated after interventional treatment, rapid progress of lesion in non-intervention site;5 Surgical mortality is low in regardless of interventional therapy or bypass surgery, but the rate of revascularization is significantly higher in following 10 years.
Detailed description
Study method
- Recruited the patients meet the inclusion criteria since March 2016, collected the information of the change of risk factors, angina in pre-operation, mode of onset, characteristics of coronary artery, morbility of treatment,clinical follow-up; ② Collect the following information in clinical cases: gender, age, history of hypertension, history of diabetes, cholesterol level, triglyceride level, sedentary, body index, family history of CHD, genotype of ALDH2 and MTHFR, history of myocardial infarction, coronary artery lesions and operation situation; ③ The follow-up was performed through clinic and telephone every half or one year. The details include whether recurrence of angina, the main symptom, the cause of attack, lasting time, the efficacy of taking nitroglycerin, whether performed electrocardiography examination, whether occurred myocardial infarction and the attack site. whether performed interventional therapy and CABG surgery again and the cause of surgery, whether re-examined coronary arteriongraphy, whether death and the cause, and the occurred date in above events; ④ Analysis the pathogenic intensity with each risk factors with other age group CHD.
3.2 Study population 3.2.1 inclusion criteria
Young CHD group:
- Below or equal to 45 years of age; ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan; ③ Signed informed consent form. Non-young CHD group
- Below or equal to 45 years of age; ② Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by Coronary angiography or coronary CT scan; ③ Risk factors such as the gender, high cholesterol, high blood pressure, overweight, diabetes, smoking, homocysteine levels matched with inclusion criteria 1 subjects enrolled. ④ Signed informed consent form Young non-coronary heart disease
- Below or equal to 45 years of age; ② Patients were confirmed to rule out the stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by Coronary angiography or coronary CT scan; ③ Signed Informed consent form. 3.2.2 Exclusion criteria Exclusion criteria in each group are as follows
- Patients who suffered serious liver and kidney diseases, infections, severe systemic disease such as blood disease and malignant tumor; ② Pregnancy or breast-feeding women;
- Patients who could not timely follow up or refuse to participate in this study. 3.2.3 Exit criteria Subjects were claimed to withdraw informed consent. 3.3 Grouping method and cases number
- Experimental group：1250 samples
- Positive control group：1250 samples ③ Negative control group：500 samples
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD Patients | – | –coronary angioplasty confirmed coronary heart disease. |
| non-CHD patients | – | –coronary angioplasty confirmed no coronary heart disease. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ①Below or equal to 45 years of age; ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan;
Key inclusion criteria (1 listed)
- ②Patients suffered stable or latent coronary heart disease, unstable angina, non-ST segment elevation myocardial infarction or ST segment elevation myocardial infarction diagnosed by coronary angiography or coronary CT scan
Key exclusion criteria (1 listed)
- Patients who suffered serious liver and kidney diseases, infections, severe systemic disease such as blood disease and malignant tumor; ②Pregnancy or breast-feeding women; ③Patients who could not timely follow up or refuse to participate in this study.
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 |
|---|---|---|
| Other | CHD Patients, non-CHD patients |
Primary outcome
heart failure
Time frame: 12 months
LVEF less than 40%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Individual participant dataSharing planned: Undecided. laboratory test
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor, Cardiovascular, Young CHD Patients, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 1 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart failure (time frame: 12 months). 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 2 Feb 2017.