Bleeding Clinical Trial
NCT number | NCT02849691 |
Other study ID # | DPP4a-noreflow |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 24, 2016 |
Last updated | July 26, 2016 |
Start date | January 2014 |
Verified date | July 2016 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 747 |
Est. completion date | |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - a diagnosis of STEMI and needed PCI Exclusion Criteria: - patients with cancer - patients who used DPP4 inhibitor - patients who used GLP1 analogue |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | a change in the prevalence of no-reflow | TIMI flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow | immediately after PCI | No |
Secondary | in-hospital major adverse cardiac or cerebrovascular events | the composite of death, nonfatal MI, or stroke | up to 2 week after PCI (until discharge) | No |
Secondary | in-hospital complications | 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) | No |
Secondary | in-hospital major bleeding | 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) | No |
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