Myocardial InfarctionNCT03691246
Research on Burden of Disease for Patients With Myocardial Infarction Combining Dyslipidemia in China
An observational study of Myocardial Infarction and Dyslipidemias, run by China Cardiovascular Association at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction, Dyslipidemias
- How many people
- 900 participants
- Where
- 5 sitesChina
- Study dates
- 15 Nov 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Tao Jianhong, MD, taojianhong06@163.com
Huang Hao, 34266129@qq.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Chen Jiyan, MD, 020-83827812, chen-jiyan@163.com
He Peiyu, emily_hpy@126.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Xu Biao, MD, xubiao62@nju.edu.cn
Li Peiwen, MD, 13805174693@163.com
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Ge Junbo, MD, ge.junbo@zs-hospital.sh.cn
Wang Zhen, MD, wang.zhen1@zs-hospital.sh.cn
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Su Xi, MD, yaxin_suxi@163.com
Shuang Dongsi, sds97@163.com
About this study
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:
- patient compliance with medication;
- health-related quality of life (HRQoL) in patients.
Read the 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.
- Conditions
- Myocardial Infarction, Dyslipidemias
- Keywords
- Myocardial Infarction, Dyslipidemia
- Medical subject headings
- Myocardial Infarction, Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 3 years
Secondary outcomes (2)
Health-related quality of life
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).
Measured: 2 to 3 years
patient compliance with medication
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.
Measured: 2 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 Nov 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Cardiovascular Association
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shanghai Zhongshan Hospital, Guangdong Provincial People's Hospital, Sichuan Provincial People's Hospital, Wuhan Asia Heart Hospital
- Responsible party
- Sponsor
- Investigators
- Yong Huo, master, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691246
- Sponsor's protocol ID
- GUSU17003
- Status last verified
- Nov 2018
- First submitted
- 22 Sep 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16214597Bays 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.
PubMed 18346311Joffres 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.
PubMed 23823891Alhabib 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.
PubMed 22156634Tuppin 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.
PubMed 27079468Mota 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.
PubMed 27938835Moran 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.
PubMed 20442213Authors/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.
PubMed 27594540
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Burden of Disease for Patients With Myocardial Infarction Combining Dyslipidemia in China
- ClinicalTrials.gov ID
- NCT03691246
- Acronym / sponsor ID
- GUSU17003
- Conditions
- Myocardial Infarction, Dyslipidemias
- Keywords
- Myocardial Infarction, Dyslipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- China Cardiovascular AssociationUniversity, hospital or other
- Collaborators
- Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shanghai Zhongshan Hospital, Guangdong Provincial People's Hospital, Sichuan Provincial People's Hospital, Wuhan Asia Heart Hospital
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- patient compliance with medication;
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Health-related quality of life
Time frame: 2 to 3 years
patient compliance with medication
Time frame: 2 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 16214597Baigent 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.
- Background: PubMed 18346311Bays 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.
- Background: PubMed 23823891Joffres 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.
- Background: PubMed 22156634Alhabib 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.
- Background: PubMed 27079468Tuppin 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.
- Background: PubMed 27938835Mota 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.
- Background: PubMed 20442213Moran 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.
- Background: PubMed 27594540Authors/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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, master principal investigator
Peking University First Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Dyslipidemias, run by China Cardiovascular Association at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Huo, master (13901333060, drhuoyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Economic burden of disease (time frame: 2 to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691246, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.