## Protocol Section
### Identification Module
**NCT ID:** NCT03351179

**Brief Title:** Predictors and Outcomes of In-hospital HFpEF in AMI Patients

**Official Title:** Predictors and Outcomes of Hospitalized Heart Failure With Preserved Ejection Fraction Among Patients With First Acute Myocardial Infarction After Reperfusion Treatments

#### Organization Study ID Info
**ID:** FirstSoochowU
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital of Soochow University
### Status Module
#### Completion Date
**Date:** 2018-12-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2019-01-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-01-01

**Type:** ACTUAL

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2017-11-22
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-04
**Study First Submit QC Date:** 2017-11-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xiangjun Yang

#### Responsible Party

**Investigator Affiliation:** The First Affiliated Hospital of Soochow University

**Investigator Full Name:** Xiangjun Yang

**Investigator Title:** Director, department of cardiology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This retrospective observation is to investigate the incidence,clinical outcomes and prognosis of hospitalized heart failure with preserved ejection fraction (HFpEF) in patients with acute myocardial infarction(AMI).

**Detailed Description:** 1. Patients with first AMI undergoing primary percutaneous coronary intervention (PCI) in our hospital since January 2013 were retrospectively evaluated. The enrolled subjects were divided into two groups (AMI patients with HFpEF and AMI patients without HF).
2. The investigator collected the clinical data of participants' demographics (age, sex), previous history,risk factors for AMI (hypertension, hyperlipidemia, diabetes mellitus, smoking and stroke), laboratory biomarkers, echocardiographic measurements, clinical characteristics,medical procedures and treatments, as well as in-hospital complications.
3. Two sub-investigators independently analyzed these data by using SPSS software.

### Conditions Module

**Conditions:**

- Acute Myocardial Infarction

- Heart Failure With Preserved Ejection Fraction

- Predictor

- Prognosis

**Keywords:**

- Heart Failure with Preserved Ejection Fraction

- Acute MyocAcute Myocardial Infarction

- Predictive factors

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Combination Product: clinical characteristics, previous history, laboratory bio-markers, echocardiographic measurements, angiographic findings,clinical outcomes

**Label:** AMI patients with HFpEF

#### Arm Group 2

**Intervention Names:**

- Combination Product: clinical characteristics, previous history, laboratory bio-markers, echocardiographic measurements, angiographic findings,clinical outcomes

**Label:** AMI patients without HF

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AMI patients with HFpEF

- AMI patients without HF

**Description:** The differences of data(clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic characteristics and clinical outcomes) in two groups were conducted. The differences between two groups were compared (clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic characteristics and clinical outcomes) in two groups were compared, and then found the risk factors. Following,the incidence of clinical outcomes and mortality were compared. Then, univariate logistic regression and multivariate logistic regression analysis adjusted for significant risk factors were performed to find out the independent predictive factors. Finally, the ROC was constructed, and the area was evaluated to assess the predicted probability of regression model.

**Name:** clinical characteristics, previous history, laboratory bio-markers, echocardiographic measurements, angiographic findings,clinical outcomes

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Measure:** Risk factors of incident in-hospital HFpEF

**Time Frame:** Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.

#### Secondary Outcomes

**Measure:** Clinical prognosis in patients with HFpEF

**Time Frame:** Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* First AMI patients undergoing PCI with HFpEF or without HF.

Exclusion Criteria:

* First AMI patients with heart failure with reduced ejection fraction.
* First AMI patients with severe inflammatory diseases, valvular heart disease, non-cardiac caused symptoms, serious hepatic and renal failure, congenital cardiomyopathy,or pericardial diseases.

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** AMI patients with HFpEF: First AMI subjects undergoing PCI with a diagnosis of HFpEF.

AMI patients without HF: First AMI subjects undergoing PCI without a diagnosis of HF.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Suzhou

**Country:** China

**Facility:** the First Affiliated Hospital of Soochow University

**State:** Jiangsu

**Zip:** 215006

#### Overall Officials

**Official 1:**

**Affiliation:** First Affiliated Hospital of Soochow University

**Name:** Xiangjun Yang, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000007238

- Term: Infarction

### Misc Info Module

- Version Holder: 2024-05-24
