Coronary Artery DiseaseRIPPERNCT02692014
Risk Factors Promoting Coronary Plaque Progression In China
An observational study of Coronary Artery Disease, run by Zhang Qi, MD at 1 site in China.
Trial summary
Coronary drug-eluting stent (DES) has been launched in China for more than ten years. Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit the progression of atherosclerosis plaque outside segments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will take 12 months to collect data of 2,400 cases in 20 CHD intervention centers of China and following 9 months to compete QCA and risk factors analysis.
Who may be able to join
- Age ≥18 years
- more than 2 times of CAG in the same coronary intervention center
- within 12-24 months during Jun 2013 to Dec 2016
Who cannot join
- CABG history prior to the last record of CAG
- poor imaging quality of CAG
- not consistent with the requirements of QCA analysis
- mediated by other non-atherosclerosis factors such as arteritis
- pregnant
- other factors considered as not appropriate for inclusion by investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Multicenter Retrospective Observational Study on Different Risk Factors in Coronary Artery Stenosis Progression of CHD in China
Coronary drug-eluting stent (DES) has been launched in China for more than ten years. Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit the progression of atherosclerosis plaque outside segments. It was shown that the progression rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which indicated that current secondary prevention for coronary heart disease (CHD) is far from the achievement of ideal conditions.
Atherosclerosis has many risk factors based on current CHD guidelines, among which the level of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins were performed in the world during the past 20 years. It was demonstrated in these studies that statins were significant to both primary and secondary preventions of CHD. What's more, the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is achieved. However, cardiovascular events were still not avoidable especially for the secondary prevention of CHD even if the level of LDL was significantly controlled under the recommended range of guidelines by high dosage of statins.
Read more
It was shown in some recent studies that high loading dosage of statins may effectively control the progression of coronary plaque. However, multiple studies found it was hard to control the progression of all patients of coronary plaque due to individual difference.
Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of all statins because of possible high safety issues and confusions about the appropriate application in Chinese patients, as well as economy burden to Chinese patients with high treatment cost. How to evaluate individual progression risk of coronary plaque and enhance risk factors control and the treatment of statins for necessary population, is currently an issue, which should be solved in the diagnosis and treatment of CHD.
The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes and chronic kidney diseases may also be associated with the progression of plaque. However, the potential impact and control are still uncertain up to date.
Based on these background, we design a retrospective study, Risk Factors Promoting Coronary Plaque Progression In China (The RIPPER Study), to solve these issues.
Read the detailed description
STUDY DESIGN This is a national multicenter retrospective study. Through reviewing angiography database in 20 CHD intervention centers of China. We will collect the data of 2400 patients with twice of coronary angiography as well as 12-24 months interval from Jun 2013 to Dec 2016. We will confirm the actual rate in the coronary plauqe progression of CHD patients in China as well as regression analysis to investigate the impact of different risk factors on the progression of coronary plaque, thus find the primary risk factors and rational strategy in secondary prevention. In this study, the included patients should not be replaced or withdrawal.
STUDY POPULATION 2,400 patients who are diagnosed with CHD and have received more than 2 times of coronary angiography within 12-24 months will be enrolled. If the number of angiography is more than 2 times. Patients who receive examination not in the same coronary intervention center will not be included.
STUDY DURATION It will take 12 months to collect data of 2,400 cases in 20 CHD intervention centers of China and following 9 months to compete QCA and risk factors analysis STUDY PROCESS The statistical analysis will include all the materials of cases. We will describe the basic history characteristics of patients, test parameters and the imaging characteristics of coronary angiography. Continuous variables will be described by number, mean, standard deviation (SD), median, minimum value and maximum value. Numeric variables with normal distribution will be described by mean and SD. Continuous variables will be compared by student test (normal distribution) and Wilcoxon rank sum test (skew distribution). Categorical variables (nominal variables/rank variables) will be described as frequency and percentage, which can be compared by Chi square test or Fisher exact test. Logistic multiple regression can be used to evaluate the risk factors of coronary disease progression in Chinese patients, among which the possible risk factors selection is based on clinical and statistical decision. Receiver operating characteristic(ROC) curve can be used to establish risk evaluation model of coronary disease progression and evaluate its value. The incomplete data will not be analyzed.
Data analysis will be processed by SPSS 13.0. All the analysis will be used the 2-side test or 2-side 95% confidence interval. There is statistical significance if 2-side P value is less than 0.05. This study will use descriptive analysis and finally report primary and secondary outcomes by graphics.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| coronary heart disease | 2,400 patients who are diagnosed with CHD and have received more than 2 times of coronary angiography within 12-24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors
Risk factors of the decreased diameter of in situ coronary stenosis (percentage) or vascular occlusion is analyzed by QCA
Measured: 12 months
Secondary outcomes (3)
The extent of decreased diameter of in situ coronary stenosis
analysed by QCA
Measured: 12 months
The progression of coronary stenosis
observed by coronary angiography(CAG), defined as 20% increase of stenosis without intervention.
Measured: 12 months
ISR
The incidence of in stent restenosis
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 posted25 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (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.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Qi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692014
- Sponsor's protocol ID
- RJH20160126
- Acronym
- RIPPER
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Observational Study on Different Risk Factors in Coronary Artery Stenosis Progression of CHD in China
- ClinicalTrials.gov ID
- NCT02692014
- Acronym / sponsor ID
- RIPPER / RJH20160126
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Zhang Qi, MDUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Feb 2016 (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 drug-eluting stent (DES) has been launched in China for more than ten years. Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit the progression of atherosclerosis plaque outside segments. It was shown that the progression rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which indicated that current secondary prevention for coronary heart disease (CHD) is far from the achievement of ideal conditions.
Atherosclerosis has many risk factors based on current CHD guidelines, among which the level of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins were performed in the world during the past 20 years. It was demonstrated in these studies that statins were significant to both primary and secondary preventions of CHD. What's more, the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is achieved. However, cardiovascular events were still not avoidable especially for the secondary prevention of CHD even if the level of LDL was significantly controlled under the recommended range of guidelines by high dosage of statins.
It was shown in some recent studies that high loading dosage of statins may effectively control the progression of coronary plaque. However, multiple studies found it was hard to control the progression of all patients of coronary plaque due to individual difference.
Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of all statins because of possible high safety issues and confusions about the appropriate application in Chinese patients, as well as economy burden to Chinese patients with high treatment cost. How to evaluate individual progression risk of coronary plaque and enhance risk factors control and the treatment of statins for necessary population, is currently an issue, which should be solved in the diagnosis and treatment of CHD.
The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes and chronic kidney diseases may also be associated with the progression of plaque. However, the potential impact and control are still uncertain up to date.
Based on these background, we design a retrospective study, Risk Factors Promoting Coronary Plaque Progression In China (The RIPPER Study), to solve these issues.
Detailed description
STUDY DESIGN This is a national multicenter retrospective study. Through reviewing angiography database in 20 CHD intervention centers of China. We will collect the data of 2400 patients with twice of coronary angiography as well as 12-24 months interval from Jun 2013 to Dec 2016. We will confirm the actual rate in the coronary plauqe progression of CHD patients in China as well as regression analysis to investigate the impact of different risk factors on the progression of coronary plaque, thus find the primary risk factors and rational strategy in secondary prevention. In this study, the included patients should not be replaced or withdrawal.
STUDY POPULATION 2,400 patients who are diagnosed with CHD and have received more than 2 times of coronary angiography within 12-24 months will be enrolled. If the number of angiography is more than 2 times. Patients who receive examination not in the same coronary intervention center will not be included.
STUDY DURATION It will take 12 months to collect data of 2,400 cases in 20 CHD intervention centers of China and following 9 months to compete QCA and risk factors analysis STUDY PROCESS The statistical analysis will include all the materials of cases. We will describe the basic history characteristics of patients, test parameters and the imaging characteristics of coronary angiography. Continuous variables will be described by number, mean, standard deviation (SD), median, minimum value and maximum value. Numeric variables with normal distribution will be described by mean and SD. Continuous variables will be compared by student test (normal distribution) and Wilcoxon rank sum test (skew distribution). Categorical variables (nominal variables/rank variables) will be described as frequency and percentage, which can be compared by Chi square test or Fisher exact test. Logistic multiple regression can be used to evaluate the risk factors of coronary disease progression in Chinese patients, among which the possible risk factors selection is based on clinical and statistical decision. Receiver operating characteristic(ROC) curve can be used to establish risk evaluation model of coronary disease progression and evaluate its value. The incomplete data will not be analyzed.
Data analysis will be processed by SPSS 13.0. All the analysis will be used the 2-side test or 2-side 95% confidence interval. There is statistical significance if 2-side P value is less than 0.05. This study will use descriptive analysis and finally report primary and secondary outcomes by graphics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary heart disease | – | –2,400 patients who are diagnosed with CHD and have received more than 2 times of coronary angiography within 12-24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will take 12 months to collect data of 2,400 cases in 20 CHD intervention centers of China and following 9 months to compete QCA and risk factors analysis.
Key inclusion criteria (3 listed)
- Age ≥18 years
- more than 2 times of CAG in the same coronary intervention center
- within 12-24 months during Jun 2013 to Dec 2016
Key exclusion criteria (6 listed)
- CABG history prior to the last record of CAG
- poor imaging quality of CAG
- not consistent with the requirements of QCA analysis
- mediated by other non-atherosclerosis factors such as arteritis
- pregnant
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
Risk factors
Time frame: 12 months
Risk factors of the decreased diameter of in situ coronary stenosis (percentage) or vascular occlusion is analyzed by QCA
3 secondary outcomes
The extent of decreased diameter of in situ coronary stenosis
Time frame: 12 months
The progression of coronary stenosis
Time frame: 12 months
ISR
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Zhang Qi, MD 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 3 inclusion and 6 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 25 Feb 2016. 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?
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?
Risk factors (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 25 Feb 2016.