NCT03351179

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

6 years

First QC Date

November 4, 2017

Last Update Submit

December 30, 2018

Conditions

Keywords

Heart Failure with Preserved Ejection FractionAcute MyocAcute Myocardial InfarctionPredictive factors

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Study Arms (2)

AMI patients with HFpEF

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

AMI patients without HF

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

Interventions

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 with HFpEFAMI patients without HF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Study Officials

  • Xiangjun Yang, PhD

    First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, department of cardiology

Study Record Dates

First Submitted

November 4, 2017

First Posted

November 22, 2017

Study Start

January 1, 2013

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations