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

NCT ID: NCT03691246

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Dyslipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Wuhan Asia Heart Hospital

OTHER

Sponsor Role collaborator

China Cardiovascular Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Huo, master

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Huo, master

Role: CONTACT

13901333060

Yan Zhang, doctor

Role: CONTACT

13621062738

Facility Contacts

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Chen Jiyan, MD

Role: primary

020-83827812

He Peiyu

Role: backup

Su Xi, MD

Role: primary

Shuang Dongsi

Role: backup

Xu Biao, MD

Role: primary

Li Peiwen, MD

Role: backup

Ge Junbo, MD

Role: primary

Wang Zhen, MD

Role: backup

Tao Jianhong, MD

Role: primary

Huang Hao

Role: backup

References

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Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.

Reference Type BACKGROUND
PMID: 16214597 (View on PubMed)

Bays HE, Chapman RH, Fox KM, Grandy S; SHIELD Study Group. Comparison of self-reported survey (SHIELD) versus NHANES data in estimating prevalence of dyslipidemia. Curr Med Res Opin. 2008 Apr;24(4):1179-86. doi: 10.1185/030079908x280527. Epub 2008 Mar 14.

Reference Type BACKGROUND
PMID: 18346311 (View on PubMed)

Joffres M, Shields M, Tremblay MS, Connor Gorber S. Dyslipidemia prevalence, treatment, control, and awareness in the Canadian Health Measures Survey. Can J Public Health. 2013 Apr 24;104(3):e252-7. doi: 10.17269/cjph.104.3783.

Reference Type BACKGROUND
PMID: 23823891 (View on PubMed)

Alhabib KF, Sulaiman K, Al-Motarreb A, Almahmeed W, Asaad N, Amin H, Hersi A, Al-Saif S, AlNemer K, Al-Lawati J, Al-Sagheer NQ, AlBustani N, Al Suwaidi J; Gulf RACE-2 investigators. Baseline characteristics, management practices, and long-term outcomes of Middle Eastern patients in the Second Gulf Registry of Acute Coronary Events (Gulf RACE-2). Ann Saudi Med. 2012 Jan-Feb;32(1):9-18. doi: 10.5144/0256-4947.2012.9.

Reference Type BACKGROUND
PMID: 22156634 (View on PubMed)

Tuppin P, Riviere S, Rigault A, Tala S, Drouin J, Pestel L, Denis P, Gastaldi-Menager C, Gissot C, Juilliere Y, Fagot-Campagna A. Prevalence and economic burden of cardiovascular diseases in France in 2013 according to the national health insurance scheme database. Arch Cardiovasc Dis. 2016 Jun-Jul;109(6-7):399-411. doi: 10.1016/j.acvd.2016.01.011. Epub 2016 Apr 11.

Reference Type BACKGROUND
PMID: 27079468 (View on PubMed)

Mota D, Mattos AC, Oliveira G, Avezum A. The Need for Brazil to Focus on CVD. Glob Heart. 2016 Dec;11(4):439-440. doi: 10.1016/j.gheart.2016.10.001. No abstract available.

Reference Type BACKGROUND
PMID: 27938835 (View on PubMed)

Moran A, Gu D, Zhao D, Coxson P, Wang YC, Chen CS, Liu J, Cheng J, Bibbins-Domingo K, Shen YM, He J, Goldman L. Future cardiovascular disease in china: markov model and risk factor scenario projections from the coronary heart disease policy model-china. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):243-52. doi: 10.1161/CIRCOUTCOMES.109.910711. Epub 2010 May 4.

Reference Type BACKGROUND
PMID: 20442213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27594540 (View on PubMed)

Other Identifiers

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GUSU17003

Identifier Type: -

Identifier Source: org_study_id

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