ClinicalTrials.gg
CompletedNCT03312179Updated Oct 19, 2017

STEMI and Incretins Treatment

An observational study in STEMI, Coronary Artery Disease and Coronary Syndrome, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by University of Campania Luigi Vanvitelli · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
900
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 70 studies in ST Elevation Myocardial Infarction with a site in Italy — 13 open to participants now, 17 under way, 1 of them phase 3. ST Elevation Myocardial Infarction · Italy.

Enrollment
10th of 29
900 · median 350
Started
2017
with 2 others
Observational
29 of 70
7 open now
Registered
36th of 70
by date
Lead sponsor
2 of 70
University of Campania Luigi Vanvitelli

Among the 70 studies in ST Elevation Myocardial Infarction with a site in Italy, this one is the 10th largest by enrollment of the 29 observational ones that give a count, is one of 3 that started in 2017, is one of 29 observational ones, and was the 36th registered.

ST Elevation Myocardial Infarction

851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

13 of the 70 studies in ST Elevation Myocardial Infarction with a site in Italy are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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. 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.

03

Conditions studied

  • STEMI
  • Coronary Artery Disease
  • Coronary Syndrome
  • Coronary Arteriosclerosis
  • Diabetes
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

aged >18, first STEMI, STEMI with multi vessels coronary stenosis.

Exclusion criteria

Exclusion Criteria:

aged \< 18, renal impairment, mono vessel STEMI, severe depression of left ventricle (LVEF \<35%).

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
900 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

    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.

    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.

    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.

    Device: PCI and DES stenting

Interventions

  • DevicePCI and DES stenting

    Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.

  • Patients treated before study enrollment by incretin drugs (6 months drugs exposure)

06

What researchers measure

Primary outcomes

  1. all cause deaths

    at 12 months follow up authors monitored and reported all cause mortality

    Time frame: 12 months

  2. cardiac deaths

    at 12 months follow up authors monitored and reported mortality events due to cardiac causes

    Time frame: 12 months

  3. MACE

    authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.

    Time frame: 12 months

07

Study locations

1 site
  • Raffaele Marfella
    Naples, 80128, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Sep 2017, 8 months.

Of 122 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's 8 months is below that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 20 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 17, 2017
StartActual
Jan 1, 2017
Primary completionActual
Sep 1, 2017
CompletionActual
Oct 1, 2017
Last update
Oct 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312179
Responsible party
Celestino Sardu (MD, MSc, PHD, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Oct 17, 2017
Start date
Jan 1, 2017
Primary completion
Sep 1, 2017
Completion
Oct 1, 2017
Last update
Oct 19, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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