STEMI and Incretins Treatment

NCT03312179 | Completed DMC FDA Drug FDA Device

• 1 other identifier: 9/2017
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI; Coronary Artery Disease; Coronary Syndrome; Coronary Arteriosclerosis; Diabetes

Outcome Measures

Primary Outcomes (3)

• all cause deaths

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

  12 months

• cardiac deaths

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

  12 months

• MACE

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

  12 months

Study Arms (4)

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

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

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; Drug: Incretins

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

Interventions

PCI and DES stenting DEVICE

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

diabetics STEMI; diabetics incretin-users STEMI; diabetics never-incretin-users STEMI; non diabetics STEMI

Incretins DRUG

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

diabetics incretin-users STEMI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, 80128, Italy

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease; Angina, Unstable; Diabetes Mellitus

Interventions

Percutaneous Coronary Intervention; Incretins

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PHD

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

IT (1)