Risk Factors Promoting Coronary Plaque Progression In China

NCT02692014 | Unknown DMC

• 1 other identifier: RJH20160126
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Risk factors

  Risk factors of the decreased diameter of in situ coronary stenosis (percentage) or vascular occlusion is analyzed by QCA

  12 months

Secondary Outcomes (3)

• The extent of decreased diameter of in situ coronary stenosis

  12 months

• The progression of coronary stenosis

  12 months

• ISR

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhang Qi, MD: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief doctor

Study Record Dates

• First Submitted: February 21, 2016
• First Posted: February 25, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

CN (1)