NCT03312179

STEMI and Incretins Treatment

STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 900 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-09-01
• Completion: 2017-10-01
• First posted: 2017-10-17
• Last updated: 2017-10-19

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study
• FDA-regulated device study