Coronary AngiographyNCT03046576
Prognostic Value of Plasma DPP4 Activity in ST-elevation Myocardial Infarction Patients
An observational study of Coronary Angiography and Dipeptidyl Peptidase 4, run by Chinese PLA General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Dipeptidyl Peptidase 4
- What is being tested?
- plasma DPP4 activity
- How many people
- 625 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with STEMI who were admitted to the Chinese PLA General Hospital for PCI
Who may be able to join
- consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.
Who cannot join
- patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue
About this study
Official title: 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.
- Conditions
- Coronary Angiography, Dipeptidyl Peptidase 4
- Being tested
- plasma DPP4 activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma DPP4 activityDiagnostic test
DPP4a was determined by enzymatic assays.
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac or cerebrovascular events
including cardiovascular death, non-fatal myocardial infarction, heart failure and stroke
Measured: The median follow-up was 30 months
Secondary outcomes (3)
non-cardiovascular death
Measured: The median follow-up was 30 months
repeated revascularization
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
Measured: The median follow-up was 30 months
stroke
defined using the World Health Organization criteria
Measured: The median follow-up was 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Jan 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Jing Wei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046576
- Sponsor's protocol ID
- DPP4a-MACCE
- Status last verified
- Jul 2017
- First submitted
- 5 Feb 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26318108Zheng 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.
PubMed 24968315Li 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.
PubMed 28000723Niccoli 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.
PubMed 20837571Pellaton 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.
PubMed 26386802Li 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.
PubMed 28587613
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Plasma DPP4 Activity And Prognosis of Patients With ST-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03046576
- Acronym / sponsor ID
- DPP4a-MACCE
- Conditions
- Coronary Angiography, Dipeptidyl Peptidase 4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with STEMI who were admitted to the Chinese PLA General Hospital for PCI
Key inclusion criteria (1 listed)
- consecutive patients of acute STEMI come to our department,absent of cardiogenic shock, and survival for at least 24 h after PCI treatment.
Key exclusion criteria (1 listed)
- patients with cancer, and patients who were taking a DPP4 inhibitoror a glucagon-like peptide-1 (GLP-1) analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma DPP4 activityDPP4a was determined by enzymatic assays. | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
non-cardiovascular death
Time frame: The median follow-up was 30 months
repeated revascularization
Time frame: The median follow-up was 30 months
stroke
Time frame: The median follow-up was 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 26318108Zheng 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.
- Background: PubMed 24968315Zheng 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.
- Background: PubMed 28000723Li 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.
- Background: PubMed 20837571Niccoli 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.
- Background: PubMed 26386802Pellaton 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.
- Derived from this study: PubMed 28587613Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Angiography and Dipeptidyl Peptidase 4, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac or cerebrovascular events (time frame: The median follow-up was 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046576, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.