- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206593
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure
June 29, 2017 updated by: Faye Jiang, Guangdong Provincial People's Hospital
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong General Hospital
-
Contact:
- Anping Cai, M.D.
- Phone Number: 860215989267312
- Email: caianping1983@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria: 1.Diagnosed as coronary artery disease by coronary angiography; 2. Left ventricular ejection fraction < 45% evaluated by echocardiography during index hospitalization.
-
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
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months after discharge from index hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 12 months after discharge from index hospitalization
|
All-cause mortality
|
12 months after discharge from index hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
June 29, 2017
First Submitted That Met QC Criteria
June 29, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.GDREC2017128H(R1)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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