Ischemic Heart FailureNCT03206593
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
An observational study of Ischemic Heart Failure and Lipids, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Failure, Lipids, Fasting Plasma Glucose
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2019
- How long will I take part?
- 12 Months
- 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: Participants who are diagnosed as coronary artery disease by coronary angiography and also have left ventricular ejection fraction < 45% enroll if qualified to our inclusion criteria and exclusion criteria and informed consent will be provided.
Inclusion Criteria: 1.Diagnosed as coronary artery disease by coronary angiography; 2. Left ventricular ejection fraction < 45% evaluated by echocardiography during index hospitalization.
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Exclusion Criteria: Coexistent malignant diseases; stage 3 or more of chronic kidney disease; liver dysfunction with ALT or AST higher than 3 times of normal limit range; do not want to participant in current study
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Anping Cai, M.D., 860215989267312, caianping1983@hotmail.com
About this study
Official title: Fasting Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause mortality.in patients with ischemic heart failure and left ventricular ejection fraction < 45 % evaluated by echocardiography during 12 months follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular diseases outcomes
Fatal or non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, and cardiovascular mortality
Measured: 12 months after discharge from index hospitalization
Secondary outcomes (1)
All-cause mortality
All-cause mortality
Measured: 12 months after discharge from index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faye Jiang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206593
- Sponsor's protocol ID
- No.GDREC2017128H(R1)
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT03206593
- Acronym / sponsor ID
- No.GDREC2017128H(R1)
- Conditions
- Ischemic Heart Failure, Lipids, Fasting Plasma Glucose, Cardiovascular Outcomes, All-cause Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Jul 2017 (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.
Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause mortality.in patients with ischemic heart failure and left ventricular ejection fraction < 45 % evaluated by echocardiography during 12 months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are diagnosed as coronary artery disease by coronary angiography and also have left ventricular ejection fraction < 45% enroll if qualified to our inclusion criteria and exclusion criteria and informed consent will be provided.
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
Cardiovascular diseases outcomes
Time frame: 12 months after discharge from index hospitalization
Fatal or non-fatal myocardial infarction, fatal or non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, and cardiovascular mortality
1 secondary outcome
All-cause mortality
Time frame: 12 months after discharge from index hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Failure and Lipids, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular diseases outcomes (time frame: 12 months after discharge from index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.