Predictors and Outcomes of In-hospital HFpEF in AMI Patients

December 30, 2018 updated by: Xiangjun Yang

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMI patients with HFpEF
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.
AMI patients without HF
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangjun Yang

Investigators

  • Principal Investigator: Xiangjun Yang, PhD, First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

November 4, 2017

First Submitted That Met QC Criteria

November 18, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 30, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstSoochowU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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