## Protocol Section
### Identification Module
**NCT ID:** NCT03312179

**Brief Title:** STEMI and Incretins Treatment

**Official Title:** STEMI and Mutlivessels Coronary Artery Stenosis: Effect of Incretin Treatment

#### Organization Study ID Info
**ID:** 9/2017
#### Organization
**Class:** OTHER
**Full Name:** University of Campania "Luigi Vanvitelli"
### Status Module
#### Completion Date
**Date:** 2017-10-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-10-19

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2017-10-17
**Type:** ACTUAL
**Study First Submit Date:** 2017-10-12
**Study First Submit QC Date:** 2017-10-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Campania "Luigi Vanvitelli"

#### Responsible Party

**Investigator Affiliation:** University of Campania "Luigi Vanvitelli"

**Investigator Full Name:** Celestino Sardu

**Investigator Title:** MD, MSc, PHD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**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.

**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 Module

**Conditions:**

- STEMI

- Coronary Artery Disease

- Coronary Syndrome

- Coronary Arteriosclerosis

- Diabetes

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 900

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 12 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: PCI and DES stenting

**Label:** diabetics STEMI

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: PCI and DES stenting

**Label:** non diabetics STEMI

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Device: PCI and DES stenting

- Drug: Incretins

**Label:** diabetics incretin-users STEMI

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Device: PCI and DES stenting

**Label:** diabetics never-incretin-users STEMI

### Interventions

#### Intervention 1

**Arm Group Labels:**

- diabetics STEMI

- diabetics incretin-users STEMI

- diabetics never-incretin-users STEMI

- non diabetics STEMI

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

**Name:** PCI and DES stenting

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- diabetics incretin-users STEMI

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

**Name:** Incretins

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** all cause deaths

**Time Frame:** 12 months

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

**Measure:** cardiac deaths

**Time Frame:** 12 months

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

**Measure:** MACE

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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%).

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Naples

**Country:** Italy

**Facility:** Raffaele Marfella

**Zip:** 80128

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000007238

- Term: Infarction

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M1072

- Name: ST Elevation Myocardial Infarction

- Relevance: HIGH

- As Found: STEMI

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Arteriosclerosis

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Arteriosclerosis

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22913

- Name: Coronary Stenosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: HIGH

- As Found: Arteriosclerosis

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12155

- Name: Myocardial Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M10282

- Name: Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000072657

- Term: ST Elevation Myocardial Infarction

- ID: D000001161

- Term: Arteriosclerosis

### Intervention Browse Module - Ancestors

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M27905

- Name: Incretins

- Relevance: HIGH

- As Found: TPC

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000054795

- Term: Incretins

### Misc Info Module

- Version Holder: 2024-05-24
