NCT03046576

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

February 5, 2017

Last Update Submit

July 18, 2017

Conditions

Coronary AngiographyDipeptidyl Peptidase 4

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiac or cerebrovascular events

    including cardiovascular death, non-fatal myocardial infarction, heart failure and stroke

    The median follow-up was 30 months

Secondary Outcomes (3)

  • non-cardiovascular death

    The median follow-up was 30 months

  • repeated revascularization

    The median follow-up was 30 months

  • stroke

    The median follow-up was 30 months

Interventions

plasma DPP4 activityDIAGNOSTIC_TEST

DPP4a was determined by enzymatic assays.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with STEMI who were admitted to the Chinese PLA General Hospital for PCI

You may qualify if:

  • consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.

You may not qualify if:

  • patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 26318108BACKGROUND

  • 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.

    PMID: 24968315BACKGROUND

  • 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.

    PMID: 28000723BACKGROUND

  • 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.

    PMID: 20837571BACKGROUND

  • 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.

    PMID: 26386802BACKGROUND

  • 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.

    PMID: 28587613DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Dr.

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 8, 2017

Study Start

January 1, 2013

Primary Completion

September 30, 2015

Study Completion

September 30, 2015

Last Updated

July 21, 2017

Record last verified: 2017-07