NCT02049853

Brief Summary

Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A Initiative Study is designed to improve the coordination of care for patients with acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of care starting at the EMS level including point-of-care testing of the cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.

Trial Health

57
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Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

January 28, 2014

Last Update Submit

May 19, 2015

Conditions

DyspneaHeart Failure

Keywords

acute dyspneaheart failurediagnosticsPOCT analysispreclinical area

Outcome Measures

Primary Outcomes (1)

  • Days alive and out of hospital within 30 days

    30 days

Secondary Outcomes (10)

  • Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days

    60 months

  • Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure

    1 month

  • In-hospital length of stay during follow-up of 30 and 90 days

    3 months

  • Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission

    1 month

  • Need for ICU admission during initial hospitalization

    6 months

  • +5 more secondary outcomes

Study Arms (2)

default group

NO INTERVENTION

Patients with the randomization result "default group" receive standard diagnostics

POCT group

ACTIVE COMPARATOR

patients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle

Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group

Interventions

NTproBNP measurement with point of care device "Cobash232" in the POCT groupDEVICE
POCT group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute dyspnea (NYHA II-IV)
  • age \>= 18 years
  • informed consent

You may not qualify if:

  • cardiopulmonary resuscitation \< 7 days
  • cardiogenic shock, STEMI, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty
  • systolic blood pressure lower than 100 mmHg at first contact/presentation
  • ventricular tachycardia
  • severe aortic stenosis
  • advanced neoplasm (e.g. lung cancer, hematologic neoplasm, etc.)
  • chronic kidney disease requiring hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinikum Nürnberg

Nuremberg, Bavaria, 90419, Germany

Location

Bayrisches Rotes Kreuz

Fürth, 90762, Germany

Location

Klinikum Fürth, Emergency Department

Fürth, 90766, Germany

Location

Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine

Jena, 07747, Germany

Location

DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.

Jena, 07749, Germany

Location

Johanniter-Unfall-Hilfe

Nuremberg, 90419, Germany

Location

MeSH Terms

Conditions

DyspneaHeart Failure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Michael Christ, Prof.

    Klinikum Nürnberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. Michael Christ

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

June 1, 2013

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

DE(6)