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Completed

NCT Number: NCT02996032

CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study

This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can predict patients at higher risk of readmission within 30 days of hospital discharge for decompensated heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston University

Boston, Massachusetts, 02119, United States

About this study

Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65 years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts to treat HF are difficult without a simple method to detect early signs of congestion to direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling pressures two weeks prior to other markers of congestion such as weight gain or patient symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular measure and correlates with cardiac filling pressures. Despite the relationship between FTc and filling pressures, this measure has never been studied in HF. The primary aim is to determine if FTc can predict patients at risk of readmission within 30 days. As a secondary aim, the investigators plan to validate a small study of patients reporting the ability of pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound was 100% sensitive and 68% specific for predicting readmission at 3 months, however this investigation was small and validation is needed. It is expected ultrasound will be able to accurately and safely predict patients who will be readmitted within 30 days of discharge. This proposal is aimed at identifying a noninvasive measure to better assess congestion from HF and predict readmissions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English Speaking
  • Being admitted for heart failure with expected hospital stay of 72 hours

Exclusion criteria

  • Unable to provide consent

Treatment and study plan

Vascular and Pulmonary Ultrasound

Other

Primary outcomes

  1. Change in Corrected Flow Time

    Time frame: Measured daily during hospitalization and then correlated to 30 day readmissions.Mean hospitalization for the study population is 9 days, but will be measured during the duration of their hospitalization.

    Daily corrected flow time measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of their hospitalization. Changes in corrected flow time values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Corrected Flow Time is a single measure performed serial with the same units of measure.

Secondary outcomes

  1. Change in Pulmonary Ultrasound (B-Lines)

    Time frame: Measured daily during hospitalization and correlated to 30 day readmissions. Mean hospitalization time for the study population is 9 days, but will be measured during the duration of hospitalization.

    Daily pulmonary ultrasound measures will be obtained during hospitalization. Mean hospitalization time for the study population is 9 days, but will be measured for the duration of their hospitalization. Changes in lung ultrasound values will be assessed for associations with 30 day return visits. 30 Day returns will be determined by medical record review as well as follow up phone calls to patients. Lung Ultrasound is a single measure performed serial with the same units of measure.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Emergency Medicine Foundation
  • Heart Failure Society of America

Registry information

Official study title

CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Study

Acronym: CRUSH

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2016
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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