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Completed

NCT Number: NCT00493844

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercise testing

Other

Exercise testing

Clinical evaluation + NTproBNP

Other

Clinical evaluation + NTproBNP levels

Primary outcomes

  1. Hospitalization

    Time frame: At the index episode (1 day)

Secondary outcomes

  1. Death, myocardial infarction

    Time frame: 6-12 months

  2. Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina

    Time frame: 6-12 months

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jun 28, 2007
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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