Predictors and Outcomes of In-hospital HFpEF in AMI Patients

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03351179
• Other study ID #: FirstSoochowU
• Status: Enrolling by invitation
• Start date: January 1, 2013
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2018
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Infarction
• Myocardial Infarction
• Predictor
• Prognosis

Intervention

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xiangjun Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors of incident in-hospital HFpEF		Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.
Secondary	Clinical prognosis in patients with HFpEF		Outcome measure will be assessed at discharge, and data will be reported through study completion, an average of 1 year.