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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00493844
Enrollment
320
Registered
2007-06-28
Start date
2007-01-31
Completion date
2009-01-31
Last updated
2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

Chest pain, Unstable angina, NT-proBNP, Exercise test.

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 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.

Interventions

Exercise testing

OTHERClinical evaluation + NTproBNP

Clinical evaluation + NTproBNP levels

Sponsors

Hospital Clinic of Barcelona
CollaboratorOTHER
University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
HospitalizationAt the index episode (1 day)

Secondary

MeasureTime frame
Death, myocardial infarction6-12 months
Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina6-12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026