Predictors and Outcomes of In-hospital HFpEF in AMI Patients

Sponsor
Xiangjun Yang (Other)
Overall Status
Unknown status
CT.gov ID
NCT03351179
Collaborator
(none)
500
1
71.9
7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Combination Product: clinical characteristics, previous history, laboratory bio-markers, echocardiographic measurements, angiographic findings,clinical outcomes

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Predictors and Outcomes of Hospitalized Heart Failure With Preserved Ejection Fraction Among Patients With First Acute Myocardial Infarction After Reperfusion Treatments
Actual Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 30, 2018
Anticipated Study Completion Date :
Dec 30, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • Xiangjun Yang

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangjun Yang, Director, department of cardiology, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT03351179
Other Study ID Numbers:
  • FirstSoochowU
First Posted:
Nov 22, 2017
Last Update Posted:
Jan 2, 2019
Last Verified:
Dec 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiangjun Yang, Director, department of cardiology, The First Affiliated Hospital of Soochow University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 2, 2019