Clinical trial NCT03691246: Research on Burden of Disease for Patients With Myocardial Infarction Combining Dyslipidemia in China
Official title: Research on Burden of Disease for Patients With Myocardial Infarction Combining Dyslipidemia in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Dyslipidemias
Keywords: Myocardial Infarction
Dyslipidemia
Lead sponsor: China Cardiovascular Association
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Shanghai Zhongshan Hospital
name: Guangdong Provincial People's Hospital
name: Sichuan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
First posted: 2018-10-01
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Economic burden of disease
timeFrame: 2 to 3 years
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 2 to 3 years
measure: patient compliance with medication
timeFrame: 2 to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, master
role: PRINCIPAL_INVESTIGATOR
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citation: Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.