- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02849691
Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding
July 26, 2016 updated by: Li Jing Wei, Chinese PLA General Hospital
Dipeptidyl-peptidase-4 (DPP4) is an important regulator of incretins and inflammation, and participates in the pathophysiological process of acute myocardial infarction (AMI).
However clinical data of DPP4a in AMI patients is sparse.
This study was to investigate the role of plasma DPP4 activity (DPP4a) in patients with ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI).
This was a analysis of consecutive patients conducted at a tertiary referral center from January 2014 to October 2015.
The investigators included 747 STEMI-patients, treated with PCI from January 2013 to October 2015.
Blood samples were collected immediately at admission.
The patients were divided into four groups according to DPP4a quartile.
Study Overview
Status
Completed
Conditions
Detailed Description
ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death.A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients.Dipeptidyl peptidase 4 (DPP4) is an exopeptidase expressed on the surface of diverse cells, cleaving off amino-terminal dipeptides with either L-proline, L-alanine or serine at the penultimate position.
As a cell surface protein, it participates in immune regulation, signal transduction and apoptosis.
DPP4 also circulates as a soluble form in the plasma.
Soluble DPP4 came from either membrane type clearance or secreted by cells like endothelial cells, with enzymatic activity.
Plasma DPP4 activity (DPP4a) are elevated in several diseases, including type 2 diabetes, obesity, atherosclerosis and osteoporosis.
Basic studies have showed that DPP4 inhibition leads improved survival and heart function after cardiac ischemia-reperfusion (I/R) injury, and this is partly due to activation of AKT (pAKT), pGSK3 and ANP pathways.
Also inhibition of DPP4 can alleviate atherosclerosis and heart failure.
Accordingly, one could hypothesize that high DPP4a may worsen myocardial I/R injury, causing poorer cardiovascular outcomes.
However, no study has evaluated whether DPP4a is associated with adverse clinical outcomes in STEMI patients.
Study Type
Observational
Enrollment (Actual)
747
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
PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China.
The investigators enrolled all patients consecutively hospitalized in PLAGH, with a diagnosis of STEMI and needed PCI.
Description
Inclusion Criteria:
- a diagnosis of STEMI and needed PCI
Exclusion Criteria:
- patients with cancer
- patients who used DPP4 inhibitor
- patients who used GLP1 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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Quartile 1
Quartile 1 of plasma DPP4 activity
|
Quartile 2
Quartile 2 of plasma DPP4 activity
|
Quartile 3
Quartile 3 of plasma DPP4 activity
|
Quartile 4
Quartile 4 of plasma DPP4 activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
a change in the prevalence of no-reflow
Time Frame: immediately after PCI
|
TIMI flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow
|
immediately after PCI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
in-hospital major adverse cardiac or cerebrovascular events
Time Frame: up to 2 week after PCI (until discharge)
|
the composite of death, nonfatal MI, or stroke
|
up to 2 week after PCI (until discharge)
|
in-hospital complications
Time Frame: up to 2 week after PCI (until discharge)
|
defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia
|
up to 2 week after PCI (until discharge)
|
in-hospital major bleeding
Time Frame: up to 2 week after PCI (until discharge)
|
defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event
|
up to 2 week after PCI (until discharge)
|
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
- Windecker S, Bax JJ, Myat A, Stone GW, Marber MS. Future treatment strategies in ST-segment elevation myocardial infarction. Lancet. 2013 Aug 17;382(9892):644-57. doi: 10.1016/S0140-6736(13)61452-X.
- Zhong J, Rajagopalan S. Dipeptidyl Peptidase-4 Regulation of SDF-1/CXCR4 Axis: Implications for Cardiovascular Disease. Front Immunol. 2015 Sep 25;6:477. doi: 10.3389/fimmu.2015.00477. eCollection 2015.
- Zhong J, Maiseyeu A, Davis SN, Rajagopalan S. DPP4 in cardiometabolic disease: recent insights from the laboratory and clinical trials of DPP4 inhibition. Circ Res. 2015 Apr 10;116(8):1491-504. doi: 10.1161/CIRCRESAHA.116.305665.
- Connelly KA, Zhang Y, Advani A, Advani SL, Thai K, Yuen DA, Gilbert RE. DPP-4 inhibition attenuates cardiac dysfunction and adverse remodeling following myocardial infarction in rats with experimental diabetes. Cardiovasc Ther. 2013 Oct;31(5):259-67. doi: 10.1111/1755-5922.12005.
- Shigeta T, Aoyama M, Bando YK, Monji A, Mitsui T, Takatsu M, Cheng XW, Okumura T, Hirashiki A, Nagata K, Murohara T. Dipeptidyl peptidase-4 modulates left ventricular dysfunction in chronic heart failure via angiogenesis-dependent and -independent actions. Circulation. 2012 Oct 9;126(15):1838-51. doi: 10.1161/CIRCULATIONAHA.112.096479. Epub 2012 Oct 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
January 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
July 24, 2016
First Submitted That Met QC Criteria
July 26, 2016
First Posted (Estimate)
July 29, 2016
Study Record Updates
Last Update Posted (Estimate)
July 29, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPP4a-noreflow
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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