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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Eleva

Brief Summary: 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.

Detailed Summary:

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, inconc
Sponsor: University of Valencia

Current Primary Outcome: Hospitalization [ Time Frame: At the index episode (1 day) ]

Original Primary Outcome: Hospitalization [ Time Frame: Index episode ]

Current Secondary Outcome:

  • Death, myocardial infarction [ Time Frame: 6-12 months ]
  • Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina [ Time Frame: 6-12 months ]


Original Secondary Outcome:

  • Death, myocardial infarction, revascularization [ Time Frame: 30 days ]
  • Death, myocardial infarction, revascularization [ Time Frame: 1 year ]


Information By: University of Valencia

Dates:
Date Received: June 26, 2007
Date Started: January 2007
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016