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

January 30, 2019 updated by: China Cardiovascular Association

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chen Jiyan, MD
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Su Xi, MD
        • Sub-Investigator:
          • Shuang Dongsi
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • NanJing Drum Tower Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xu Biao, MD
        • Sub-Investigator:
          • Li Peiwen, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan hospital
        • Contact:
        • Principal Investigator:
          • Ge Junbo, MD
        • Sub-Investigator:
          • Wang Zhen, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tao Jianhong, MD
        • Sub-Investigator:
          • Huang Hao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic burden of disease
Time Frame: 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.
2 to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 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).
2 to 3 years
patient compliance with medication
Time Frame: 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.
2 to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Cardiovascular Association

Collaborators

Peking University First Hospital
Shanghai Zhongshan Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Guangdong Provincial People's Hospital
Wuhan Asia Heart Hospital
Sichuan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

September 22, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUSU17003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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