N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain

This study has been completed.
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Juan Sanchis, University of Valencia
ClinicalTrials.gov Identifier:
NCT00493844
First received: June 26, 2007
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

The investigators' objective is to compare a new strategy combining clinical history and NT-proBNP levels versus the usual care, consisting of early exercise testing, for decision making in patients presenting to the emergency department with acute chest pain, non-diagnostic electrocardiogram and normal troponin. The investigators hypothesised that the new strategy combining clinical risk score and NT-proBNP will reduce the number of hospitalisations without increasing the number of events during the follow-up.


Condition Intervention
Chest Pain
Other: Exercise testing
Other: Clinical evaluation + NTproBNP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical History and NT-proBNP Versus Exercise Testing for Evaluation of Patients With Acute Chest Pain Without Ischemic Changes in the Electrocardiogram or Troponin Elevation

Resource links provided by NLM:


Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Hospitalization [ Time Frame: At the index episode (1 day) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death, myocardial infarction [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
  • Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clinical evaluation + Nt-proBNP
Other: Clinical evaluation + NTproBNP
Clinical evaluation + NTproBNP levels
Active Comparator: 2
Exercise testing
Other: Exercise testing
Exercise testing

Detailed Description:

In patients presenting to the emergency department with acute chest pain, the observation of ischemic changes in the electrocardiogram or troponin elevation prompts hospitalisation and, generally, invasive management. However, decision on admission or discharge is uncertain in the remaining patients. The spectrum of these patients spans from individuals without coronary artery disease to some with high risk unstable angina. An early exercise test is usually performed with the aim of guiding the decision. However, the exercise test is not available 24 hours per day/ 7 days per week, around 40% of the patients show contraindication to exercise and there are inconclusive as well as false-positive results. The limitations of the exercise test can lead to unnecessary hospitalisations. Therefore, there is room for alternative tools. Our objective was to compare a new strategy combining clinical history and NT-proBNP levels versus the usual care, consisting of early exercise testing, for decision making in these patients.

We will randomly compare a new strategy combining a previously published and validated clinical risk score (number of points according to pain characteristics and risk factors) along with NT-proBNP levels, versus the usual strategy using exercise test, for the management of patients presenting to the emergency department with acute chest pain, without ischemia in the electrocardiogram and with normal troponin. In the new strategy, high risk patients (clinical risk score =>3 points) as well as low risk patients (clinical risk score <3 points) but with NT-proBNP >110 ng/L, will be hospitalised; on the other hand, low risk patients (clinical risk score <3 points) with NT-proBNP <110 ng/L will be discharged. In the usual strategy, all patients will be allocated to early exercise test; patients will be hospitalised in case of a positive result, inconclusive result <7 METS or contraindication to exercise, whereas they will be discharged in case of a negative result or inconclusive result with >7 METS without ischemia induction. The primary endpoint will be hospitalisation during the index episode and the secondary endpoints 6-12 months death or acute myocardial infarction, and 6-12month death, myocardial infarction, postdischarge revascularization or readmission by unstable angina.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chest pain of possible coronary origin at criterion of cardiology on duty

Exclusion Criteria:

  • Chest pain of obvious non-coronary origin.
  • Electrocardiogram showing ST-segment deviation (=>1mm) or T-wave inversion (=>2mm) or atrial fibrillation.
  • Troponin elevation at any determination.
  • Heart failure at admission.
  • Renal failure (creatinine > 1.3 mg/gl).
  • Extracardiac disease with life expectancy less than 1 year.
  • Structural heart disease different to ischemic heart disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00493844

Locations
Spain
Hospital Clínico Universitario
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Juan Sanchis, MD Hospital Clínico Universitario. Valencia. Spain
Study Chair: Xavier Bosch, MD Hospital Clínic i Provincial. Barcelona. Spain
Study Director: Angel Llácer, MD Hospital Clínico Universitario. Valencia. Spain.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan Sanchis, Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT00493844     History of Changes
Other Study ID Numbers: 09-27-06
Study First Received: June 26, 2007
Last Updated: February 8, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Valencia:
Chest pain
Unstable angina
NT-proBNP
Exercise test.

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014