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STEMI and Incretins Treatment

NCT ID: NCT03312179

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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STEMI Coronary Artery Disease Coronary Syndrome Coronary Arteriosclerosis Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PCI and DES stenting

Intervention Type DEVICE

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.

PCI and DES stenting

Intervention Type DEVICE

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.

PCI and DES stenting

Intervention Type DEVICE

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

Incretins

Intervention Type DRUG

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.

PCI and DES stenting

Intervention Type DEVICE

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

Interventions

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PCI and DES stenting

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

Intervention Type DEVICE

Incretins

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

Intervention Type DRUG

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Celestino Sardu

MD, MSc, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Raffaele Marfella

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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9/2017

Identifier Type: -

Identifier Source: org_study_id