NCT01264159

Brief Summary

It is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

December 20, 2010

Last Update Submit

June 10, 2020

Conditions

Acute Heart Failure

Keywords

Developing acute heart failure

Outcome Measures

Primary Outcomes (1)

  • Prevention of acute heart failure development in acute MI patients

    Three years

Secondary Outcomes (1)

  • Improvement of clinical outcome in patients with lung impedence-guided treatments

    Three years

Study Arms (2)

Control

PLACEBO COMPARATOR
Other: Usual treatment of patients with developing acute heart failure

Lung impedence-guided treatment

ACTIVE COMPARATOR
Device: Lung impedence-guided therapy

Interventions

Lung impedence-guided therapyDEVICE
Lung impedence-guided treatment
Usual treatment of patients with developing acute heart failureOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization

You may not qualify if:

  • Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 21, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

IL(1)