Research on Burden of Disease for Patients With Myocardial Infarction Combining Dyslipidemia in China

• Conditions: Myocardial Infarction; Dyslipidemias

• Registration Number: NCT03691246
• Lead Sponsor: China Cardiovascular Association

Brief Summary

This study is medical record review and questionnaire survey on the economic burden on Chinese patients with myocardial infarction accompanied by dyslipidemia in a real-world environment.

The primary objective of the study is to investigate the economic burden of disease on patients and the factors influencing it, which may include the mode of treatment for dyslipidemia, drugs for the secondary prevention of myocardial infarction, the outcome of treatment for dyslipidemia, adverse drug reactions and major cardiovascular events.

The secondary objectives of the study include:

1. patient compliance with medication;

2. health-related quality of life (HRQoL) in patients.

Detailed Description

This study is a multicenter retrospective cohort survey study using a cross-sectional design. It is conducted mainly by a medical record review, questionnaire survey and medical examination to collect data.

Study Timeline

• Study First Submitted: 2018-09-22
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-10-01
• Status Verified: 2018-11
• Study Start: 2018-11-15
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Patients were hospitalized because of acute myocardial infarction in a study hospital between January 1, 2016 and December 31, 2016. If a patient was hospitalized because of multiple occurrences of myocardial infarction during this period, his/her initial hospitalization because of myocardial infarction will be considered index hospitalization. Patients undergo continuous screening in a reverse order based on time.
• Patients did not die during "index hospitalization".
• Patients had Low-density lipoprotein≥1.8 mmol/L shown by the first measurement of blood lipids or were using lipid-regulating drugs at the first measurement of blood lipids during "index hospitalization" in 2016.
• Patients consent to participate in this study and grant informed consent; or the family of a patient who died before telephone screening consents to provide relevant information and grant informed consent.

Exclusion Criteria

• Patients participated in interventional clinical trials after "index hospitalization".
• Patients had paid <5 visits to the outpatient clinics of a study hospital within one year since discharge after "index hospitalization" (if patients who have died within one year since discharge after "index hospitalization").
• There is a barrier to communication with a patient or his/her family (if the patient has died); a patient or his/her family (if the patient has died) cannot correctly understand and answer questions normally.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Economic burden of disease	2 to 3 years	Total of costs for outpatient/emergency visits after discharge since "index hospitalization" (e.g., registration fees, examination fees, inspection fees, charges for drugs and other expenses), inpatient expenses (e.g., charges for percutaneous coronary intervention /coronary artery bypass graft, bed fees, charges for drugs, charges for materials, charges for nursing care and other expenses), payments for health care workers, fees for transportation, fees for accommodation and food, costs due to losses of time and capacity for physical labor for patients and their families, charges for visits to other medical institutions due to dyslipidemia and related diseases, as well as expenses for medications and health products purchased from drug stores.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	2 to 3 years	The EuroQol five dimensions questionnaire with three-level (EQ-5D-3L) scores are calculated using the scoring system for the Chinese population. Then, the mean and standard deviation of health utility values (HUVs) are reported.; EQ-5D-3L is a standardized instrument for use as a measure of health outcome. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1 point), some problems (2 points), extreme problems (3 points).
patient compliance with medication	2 to 3 years	Medication compliance is reported mainly based on the frequency of oral administration on time and the percentage of patients taking drugs on time, which are assessed by patients themselves in the questionnaire.

Trial Locations

Locations (5)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China