Dipeptidyl-peptidase-4NCT02849691
Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding
An observational study of Dipeptidyl-peptidase-4 and STEMI, run by Chinese PLA General Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dipeptidyl-peptidase-4, STEMI, PCI
- How many people
- 747 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- a diagnosis of STEMI and needed PCI
Who cannot join
- patients with cancer
- patients who used DPP4 inhibitor
- patients who used GLP1 analogue
About this study
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.
Read the 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.
- Conditions
- Dipeptidyl-peptidase-4, STEMI, PCI, No-reflow, Bleeding
- Medical subject headings
- ST Elevation Myocardial Infarction, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately after PCI
Secondary outcomes (3)
in-hospital major adverse cardiac or cerebrovascular events
the composite of death, nonfatal MI, or stroke
Measured: up to 2 week after PCI (until discharge)
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
Measured: up to 2 week after PCI (until discharge)
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
Measured: up to 2 week after PCI (until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dipeptidyl-peptidase-4Studies 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
- Retrospective
- Enrolment
- 747 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
- NCT02849691
- Sponsor's protocol ID
- DPP4a-noreflow
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
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.
PubMed 23953388Zhong 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.
PubMed 26441982Zhong 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.
PubMed 25858071Connelly 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.
PubMed 22963483Shigeta 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.
PubMed 23035207
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding
- ClinicalTrials.gov ID
- NCT02849691
- Acronym / sponsor ID
- DPP4a-noreflow
- Conditions
- Dipeptidyl-peptidase-4, STEMI, PCI, No-reflow, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- First posted
- 29 Jul 2016 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- a diagnosis of STEMI and needed PCI
Key exclusion criteria (3 listed)
- patients with cancer
- patients who used DPP4 inhibitor
- patients who used GLP1 analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
in-hospital major adverse cardiac or cerebrovascular events
Time frame: up to 2 week after PCI (until discharge)
in-hospital complications
Time frame: up to 2 week after PCI (until discharge)
in-hospital major bleeding
Time frame: up to 2 week after PCI (until discharge)
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 29 Jul 2016.
- Background: PubMed 23953388Windecker 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.
- Background: PubMed 26441982Zhong 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.
- Background: PubMed 25858071Zhong 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.
- Background: PubMed 22963483Connelly 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.
- Background: PubMed 23035207Shigeta 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.
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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 Dipeptidyl-peptidase-4 and STEMI, 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 3 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 29 Jul 2016. 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?
a change in the prevalence of no-reflow (time frame: immediately after PCI). 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 NCT02849691, which also lists 5 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 29 Jul 2016.