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

June 26, 2007
February 8, 2013
January 2007
June 2008   (final data collection date for primary outcome measure)
Hospitalization [ Time Frame: At the index episode (1 day) ] [ Designated as safety issue: Yes ]
Hospitalisation [ Time Frame: Index episode ]
Complete list of historical versions of study NCT00493844 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Death, myocardial infarction, revascularization [ Time Frame: 30 days ]
  • Death, myocardial infarction, revascularization [ Time Frame: 1 year ]
Not Provided
Not Provided
 
N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chest Pain
  • Other: Exercise testing
    Exercise testing
  • Other: Clinical evaluation + NTproBNP
    Clinical evaluation + NTproBNP levels
  • Experimental: 1
    Clinical evaluation + Nt-proBNP
    Intervention: Other: Clinical evaluation + NTproBNP
  • Active Comparator: 2
    Exercise testing
    Intervention: Other: Exercise testing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
January 2009
June 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00493844
09-27-06
No
Juan Sanchis, University of Valencia
University of Valencia
Hospital Clinic of Barcelona
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.
University of Valencia
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP