STEMI and Incretins Treatment

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Completed
CT.gov ID
NCT03312179
Collaborator
(none)
900
1
9
100.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
900 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. all cause deaths [12 months]

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

  2. cardiac deaths [12 months]

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

  3. MACE [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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%).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Raffaele Marfella Naples Italy 80128

Sponsors and Collaborators

  • University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celestino Sardu, MD, MSc, PHD, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier:
NCT03312179
Other Study ID Numbers:
  • 9/2017
First Posted:
Oct 17, 2017
Last Update Posted:
Oct 19, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2017