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

Chest Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493844
• Other study ID #: 09-27-06
• Status: Completed
• Phase: N/A
• First received: June 26, 2007
• Last updated: October 24, 2016
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: October 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chest Pain

Intervention

Other:
• Exercise testing
Exercise testing
• Clinical evaluation + NTproBNP
Clinical evaluation + NTproBNP levels

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Sanchis J, Bodí V, Núñez J, Bertomeu-González V, Gómez C, Bosch MJ, Consuegra L, Bosch X, Chorro FJ, Llàcer A. New risk score for patients with acute chest pain, non-ST-segment deviation, and normal troponin concentrations: a comparison with the TIMI risk score. J Am Coll Cardiol. 2005 Aug 2;46(3):443-9. — View Citation

Sanchis J, Bodí V, Núñez J, Bertomeu-González V, Gómez C, Consuegra L, Bosch MJ, Bosch X, Chorro FJ, Llácer A. Usefulness of early exercise testing and clinical risk score for prognostic evaluation in chest pain units without preexisting evidence of myocardial ischemia. Am J Cardiol. 2006 Mar 1;97(5):633-5. Epub 2006 Jan 6. — View Citation

Sanchis J, Bodí V, Núñez J, Bosch MJ, Bertomeu-González V, Consuegra L, Santas E, Gómez C, Bosch X, Chorro FJ, Llàcer A. A practical approach with outcome for the prognostic assessment of non-ST-segment elevation chest pain and normal troponin. Am J Cardiol. 2007 Mar 15;99(6):797-801. Epub 2007 Jan 30. — View Citation

Sanchis J, Bosch X, Bodí V, Bellera N, Núñez J, Benito B, Ordóñez J, Consuegra L, Heras M, Llècer A. Combination of clinical risk profile, early exercise testing and circulating biomarkers for evaluation of patients with acute chest pain without ST-segment deviation or troponin elevation. Heart. 2008 Mar;94(3):311-5. — View Citation

Sanchis J, Bosch X, Bodí V, Núñez J, Doltra A, Heras M, Mainar L, Santas E, Bragulat E, García-Alvarez A, Carratalá A, Llácer A. Randomized comparison between clinical evaluation plus N-terminal pro-B-type natriuretic peptide versus exercise testing for d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization		At the index episode (1 day)	Yes
Secondary	Death, myocardial infarction		6-12 months	Yes
Secondary	Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina		6-12 months	Yes