STEMINCT03312179
STEMI and Incretins Treatment
An observational study of STEMI and Coronary Artery Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- STEMI, Coronary Artery Disease, Coronary Syndrome
- What is being tested?
- PCI and DES stenting and Incretins
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Oct 2017
- How long will I take part?
- 12 Months
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetics and non diabetics patients admitted for STEMI. In this population authors selected STEMI patients with multivessel (Mv) non obstructive coronary diseases (NOCS). These STEMI-Mv-NOCS had coronary lesions and stenosis <50%, with fractional flow reserve >0.8. In diabetics authors selected incretin users (6 months of incretin treatment before study enrollment) vs never-incretin-users diabetics.
Who may be able to join
- aged >18, first STEMI, STEMI with multi vessels coronary stenosis.
Who cannot join
- aged < 18, renal impairment, mono vessel STEMI, severe depression of left ventricle ejection fraction (LVEF <35%).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment
ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.
Read the detailed description
ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis represent a class of patients really challenging to treat. In fact, treatment, clinical management, and prognosis are supported by few literature data. Therefore, in this study authors enrolled real world patients admitted for STEMI and associated to multi vessels coronary disease. Multivessels (Mv) coronary stenosis were characterized by non obstructive coronary stenosis (NOCS) as coronary lesions <50% with fractional flow reserve > 0.8. Therefore, STEMI was treated by percutaneous coronary intervention by primary angioplasty and direct stenting (DES stenting) of culprit vessel lesion. Then these STEMI-Mv-NOCS patients were divided in diabetics vs. non diabetics, and received conventional full medical therapy for STEMI. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. Study outcomes were all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up. Authors studied these study outcomes comparing diabetics vs. non diabetics at 12 moths follow up, and diabetics incretin-users vs. never-incretin-users.
- Being tested
- PCI and DES stenting, Incretins
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease, Angina, Unstable, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI and DES stentingDevice
Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.
IncretinsDrug
Patients treated before study enrollment by incretin drugs (6 months drugs exposure)
| Study group | Role | What they receive |
|---|---|---|
| diabetics STEMI | Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. Receives: Device: PCI and DES stenting | |
| non diabetics STEMI | Non diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis(Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. Receives: Device: PCI and DES stenting | |
| diabetics incretin-users STEMI | Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These patients were treated by incretin therapy at last 6 months before study enrollment. Receives: Device: PCI and DES stenting; Drug: Incretins | |
| diabetics never-incretin-users STEMI | Diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These diabetic patients were never treated by incretin therapy before study enrollment. Receives: Device: PCI and DES stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause deaths
at 12 months follow up authors monitored and reported all cause mortality
Measured: 12 months
cardiac deaths
at 12 months follow up authors monitored and reported mortality events due to cardiac causes
Measured: 12 months
MACE
authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start1 Jan 2017
- Primary completion1 Sep 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celestino Sardu, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312179
- Sponsor's protocol ID
- 9/2017
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment
- ClinicalTrials.gov ID
- NCT03312179
- Acronym / sponsor ID
- 9/2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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.
ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. The management and prognosis of these patents are supported by few literature data. Therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for STEMI and associated to multi vessels coronary disease. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. In these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.
Detailed description
ST elevation myocardial infarction (STEMI) patients affected by multivessels coronary artery stenosis represent a class of patients really challenging to treat. In fact, treatment, clinical management, and prognosis are supported by few literature data. Therefore, in this study authors enrolled real world patients admitted for STEMI and associated to multi vessels coronary disease. Multivessels (Mv) coronary stenosis were characterized by non obstructive coronary stenosis (NOCS) as coronary lesions <50% with fractional flow reserve > 0.8. Therefore, STEMI was treated by percutaneous coronary intervention by primary angioplasty and direct stenting (DES stenting) of culprit vessel lesion. Then these STEMI-Mv-NOCS patients were divided in diabetics vs. non diabetics, and received conventional full medical therapy for STEMI. Then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. Study outcomes were all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up. Authors studied these study outcomes comparing diabetics vs. non diabetics at 12 moths follow up, and diabetics incretin-users vs. never-incretin-users.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diabetics STEMI | – | Device: PCI and DES stentingDiabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. |
| non diabetics STEMI | – | Device: PCI and DES stentingNon diabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis(Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. |
| diabetics incretin-users STEMI | – | Device: PCI and DES stenting, Drug: IncretinsDiabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These patients were treated by incretin therapy at last 6 months before study enrollment. |
| diabetics never-incretin-users STEMI | – | Device: PCI and DES stentingDiabetics patients admitted for ST elevation myocardial infarction (STEMI) and associated with multi vessels coronary artery stenosis (Mv) non obstructive coronary artery stenosis (NOCS). These patients received percutaneous coronary intervention (PCI), and primary stenting (DES) of culprit lesion. Then these patients received full medical STEMI therapy. These diabetic patients were never treated by incretin therapy before study enrollment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetics and non diabetics patients admitted for STEMI. In this population authors selected STEMI patients with multivessel (Mv) non obstructive coronary diseases (NOCS). These STEMI-Mv-NOCS had coronary lesions and stenosis <50%, with fractional flow reserve >0.8. In diabetics authors selected incretin users (6 months of incretin treatment before study enrollment) vs never-incretin-users diabetics.
Key inclusion criteria (1 listed)
- aged >18, first STEMI, STEMI with multi vessels coronary stenosis.
Key exclusion criteria (1 listed)
- aged < 18, renal impairment, mono vessel STEMI, severe depression of left ventricle ejection fraction (LVEF <35%).
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 |
|---|---|---|
| PCI and DES stentingPercutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel. | Device | diabetics STEMI, diabetics incretin-users STEMI, diabetics never-incretin-users STEMI, non diabetics STEMI |
| IncretinsPatients treated before study enrollment by incretin drugs (6 months drugs exposure) | Drug | diabetics incretin-users STEMI |
Primary outcome
all cause deaths
Time frame: 12 months
at 12 months follow up authors monitored and reported all cause mortality
cardiac deaths
Time frame: 12 months
at 12 months follow up authors monitored and reported mortality events due to cardiac causes
MACE
Time frame: 12 months
authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.
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 19 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and Coronary Artery Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
all cause deaths (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.