- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046576
Prognostic Value of Plasma DPP4 Activity in ST-elevation Myocardial Infarction Patients
July 18, 2017 updated by: Li Jing Wei, Chinese PLA General Hospital
The Association Between Plasma DPP4 Activity And Prognosis of Patients With ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention
Increased plasma DPP4 activity (DPP4a) could predict both subclinical and new-onset atherosclerosis, and our previous study has found that the DPP4a was significantly lower in MI patients compared with patients having chest pain or unstable angina alone, and DPP4a is associated with no-reflow and major bleeding events in STEMI patients during hospital stay.
As no-reflow phenomenon and major bleeding events independently associates with a worse in-hospital and long-term prognosis.
One may speculate that the DPP4a is associated with long-term follow-up adverse cardiovascular events in these patients.The hypothesis was tested in this study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
625
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with STEMI who were admitted to the Chinese PLA General Hospital for PCI
Description
Inclusion Criteria:
- consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.
Exclusion Criteria:
- patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
major adverse cardiac or cerebrovascular events
Time Frame: The median follow-up was 30 months
|
including cardiovascular death, non-fatal myocardial infarction, heart failure and stroke
|
The median follow-up was 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
non-cardiovascular death
Time Frame: The median follow-up was 30 months
|
The median follow-up was 30 months
|
|
|
repeated revascularization
Time Frame: The median follow-up was 30 months
|
defined as repeated PCI or bypass grafting of not only infarct related artery but also non-infarct related artery, driven by ischemic symptoms (stable/unstable angina or re-infarction) or detection of ischemia by non-invasive tests
|
The median follow-up was 30 months
|
|
stroke
Time Frame: The median follow-up was 30 months
|
defined using the World Health Organization criteria
|
The median follow-up was 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zheng TP, Liu YH, Yang LX, Qin SH, Liu HB. Increased plasma dipeptidyl peptidase-4 activities are associated with high prevalence of subclinical atherosclerosis in Chinese patients with newly diagnosed type 2 diabetes: a cross-sectional study. Atherosclerosis. 2015 Oct;242(2):580-8. doi: 10.1016/j.atherosclerosis.2015.07.042. Epub 2015 Jul 26.
- Zheng TP, Yang F, Gao Y, Baskota A, Chen T, Tian HM, Ran XW. Increased plasma DPP4 activities predict new-onset atherosclerosis in association with its proinflammatory effects in Chinese over a four year period: A prospective study. Atherosclerosis. 2014 Aug;235(2):619-24. doi: 10.1016/j.atherosclerosis.2014.05.956. Epub 2014 Jun 8.
- Li JW, Chen YD, Chen WR, Jing J, Liu J, Yang YQ. Plasma DPP4 activity is associated with no-reflow and major bleeding events in Chinese PCI-treated STEMI patients. Sci Rep. 2016 Dec 21;6:39412. doi: 10.1038/srep39412.
- Niccoli G, Kharbanda RK, Crea F, Banning AP. No-reflow: again prevention is better than treatment. Eur Heart J. 2010 Oct;31(20):2449-55. doi: 10.1093/eurheartj/ehq299. Epub 2010 Sep 13. No abstract available.
- Pellaton C, Cayla G, Silvain J, Zeymer U, Cohen M, Goldstein P, Huber K, Pollack C Jr, Kerneis M, Collet JP, Vicaut E, Montalescot G; ATOLL Investigators. Incidence and consequence of major bleeding in primary percutaneous intervention for ST-elevation myocardial infarction in the era of radial access: an analysis of the international randomized Acute myocardial infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up trial. Am Heart J. 2015 Oct;170(4):778-86. doi: 10.1016/j.ahj.2015.05.021. Epub 2015 Jul 3.
- Li JW, Chen YD, Chen WR, You Q, Li B, Zhou H, Zhang Y, Han TW. Prognostic value of plasma DPP4 activity in ST-elevation myocardial infarction. Cardiovasc Diabetol. 2017 Jun 6;16(1):72. doi: 10.1186/s12933-017-0553-3.
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, 2013
Primary Completion (Actual)
September 30, 2015
Study Completion (Actual)
September 30, 2015
Study Registration Dates
First Submitted
February 5, 2017
First Submitted That Met QC Criteria
February 5, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 18, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPP4a-MACCE
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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