Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT02996032
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study
Sponsor:
Boston Medical Center
Organization:
Study Overview
Official Title:
CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRUSH
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: