NCT02592135

Brief Summary

The purpose of this study is to better understand myocardial injury in AHF. Secondary analyses demonstrate the prognostic significance of troponin release. The absence of such release has been associated with less risk. Whether measurement of high sensitivity TnT may enable emergency physicians to better risk stratify acute heart failure patients remains to be determined. This study will help us to better understand the prognostic value of absent or low hsTnT values in the emergency department setting. In addition, we will also test the STRATIFY decision rule; a risk score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 21, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

June 4, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

October 28, 2015

Last Update Submit

June 1, 2018

Conditions

Heart Failure

Keywords

Acute Cardiac InsufficiencyAcute Heart Failure

Outcome Measures

Primary Outcomes (1)

  • A composite of all cause mortality and re-hospitalization, including ED re-visits

    Have increased the follow up from 30 to 90 days. Will also analyze for 30 days

    90 days

Secondary Outcomes (3)

  • Days alive and out of hospital

    90 days

  • Cardiovascular specific re-hospitalization and ED revisits

    90 days

  • Hierarchial Adverse Events Model (STRATIFY Risk Score)

    90 days

Interventions

hsTnT levelOTHER

hsTnT and NTproBNP levels at baseline and baseline plus 3 hours.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the Emergency Department (ED) with signs and symptoms of AHF

You may qualify if:

  • Age ≥21 years old
  • Patient diagnosed with acute heart failure (AHF) by the treating physician.
  • Patient has received IV loop diuretic or vasodilator therapy (by any route) for AHF
  • Provide informed written consent
  • SBP \> 100mmHg

You may not qualify if:

  • Life expectancy ≤6 months
  • Shock of any kind or use or planned use of inotropes (dobutamine, dopamine, milrinone) or vasopressors. Any form of vasodilator is allowed.
  • Fever \> 101.5
  • Presumed ACS as primary reason for presentation or ACS within 30 days. Patients with troponin release outside of ACS (Type 2 MI) may be included
  • AF with RVR \> 130bpm at any time requiring medical intervention
  • History of transplant of any kind or VAD patient
  • ESRD requiring dialysis
  • Involved in any investigational trial (observational study where there is no intervention is allowed)
  • Currently under treatment for cancer of any kind
  • Alcohol or other substance abuse
  • Any patient whom the investigator deems would be difficult to obtain follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Related Publications (1)

  • Pang PS, Fermann GJ, Hunter BR, Levy PD, Lane KA, Li X, Cole M, Collins SP. TACIT (High Sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial). Circ Heart Fail. 2019 Jul;12(7):e005931. doi: 10.1161/CIRCHEARTFAILURE.119.005931. Epub 2019 Jul 10.

    PMID: 31288565DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum specimens for bio marker analysis

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Peter S Pang, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

December 21, 2015

Primary Completion

November 7, 2017

Study Completion

May 31, 2018

Last Updated

June 4, 2018

Record last verified: 2018-06

Locations

US(5)