STEMI and Incretins Treatment

October 17, 2017 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80128
        • Raffaele Marfella

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.
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
Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.
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
Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.
Drug: Incretins
Patients treated before study enrollment by incretin drugs (6 months drugs exposure)
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
Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause deaths
Time Frame: 12 months
at 12 months follow up authors monitored and reported all cause mortality
12 months
cardiac deaths
Time Frame: 12 months
at 12 months follow up authors monitored and reported mortality events due to cardiac causes
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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