STEMI and Incretins Treatment

Coronary Artery Disease Clinical Trial

Official title:

STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312179
• Other study ID #: 9/2017
• Status: Completed
• Phase: N/A
• First received: October 12, 2017
• Last updated: October 17, 2017
• Start date: January 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: October 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Syndrome
• Diabetes
• Myocardial Ischemia
• ST Elevation Myocardial Infarction
• STEMI

Intervention

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)

Locations

Country	Name	City	State
Italy	Raffaele Marfella	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause deaths	at 12 months follow up authors monitored and reported all cause mortality	12 months
Primary	cardiac deaths	at 12 months follow up authors monitored and reported mortality events due to cardiac causes	12 months
Primary	MACE	authors monitored and reported at follow up major adverse cardiac events (MACE): re-STEMI, NSTEMI, unstable angina, arrhythmias, stroke etc.	12 months