NCT03691246

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. 1.patient compliance with medication;
  2. 2.health-related quality of life (HRQoL) in patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 31, 2019

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

September 22, 2018

Last Update Submit

January 30, 2019

Conditions

Myocardial InfarctionDyslipidemias

Keywords

Myocardial InfarctionDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Economic burden of disease

    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 Outcomes (2)

  • Health-related quality of life

    2 to 3 years

  • patient compliance with medication

    2 to 3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 16214597BACKGROUND

  • 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.

    PMID: 18346311BACKGROUND

  • 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.

    PMID: 23823891BACKGROUND

  • 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.

    PMID: 22156634BACKGROUND

  • 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.

    PMID: 27079468BACKGROUND

  • 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.

    PMID: 27938835BACKGROUND

  • 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.

    PMID: 20442213BACKGROUND

  • 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.

    PMID: 27594540BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionDyslipidemias

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yong Huo, master

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Huo, master

CONTACT

13901333060drhuoyong@163.com

Yan Zhang, doctor

CONTACT

13621062738drzhy1108@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2018

First Posted

October 1, 2018

Study Start

November 15, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 31, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)