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

NCT00493844 | Completed

• 1 other identifier: 09-27-06
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hospitalization

  At the index episode (1 day)

Secondary Outcomes (2)

• Death, myocardial infarction

  6-12 months

• Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina

  6-12 months

Study Arms (2)

1

EXPERIMENTAL

Discharge if clinical risk score \<3 points + Nt-proBNP \<110 ng/L

Other: Clinical evaluation + NTproBNP

2

ACTIVE COMPARATOR

Discharge if negative exercise testing

Other: Exercise testing

Interventions

Exercise testing OTHER

Exercise testing

2

Clinical evaluation + NTproBNP OTHER

Clinical evaluation + NTproBNP levels

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chest pain of possible coronary origin at criterion of cardiology on duty

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clínico Universitario

Valencia, Valencia, 46010, Spain

Location

Related Publications (5)

• Sanchis J, Bodi V, Nunez J, Bertomeu-Gonzalez V, Gomez C, Bosch MJ, Consuegra L, Bosch X, Chorro FJ, Llacer 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. doi: 10.1016/j.jacc.2005.04.037.

  PMID: 16053956 BACKGROUND

• Sanchis J, Bodi V, Nunez J, Bertomeu-Gonzalez V, Gomez C, Consuegra L, Bosch MJ, Bosch X, Chorro FJ, Llacer 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. doi: 10.1016/j.amjcard.2005.09.107. Epub 2006 Jan 6.

  PMID: 16490427 BACKGROUND

• Sanchis J, Bodi V, Nunez J, Bosch MJ, Bertomeu-Gonzalez V, Consuegra L, Santas E, Gomez C, Bosch X, Chorro FJ, Llacer 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. doi: 10.1016/j.amjcard.2006.10.042. Epub 2007 Jan 30.

  PMID: 17350368 BACKGROUND

• Sanchis J, Bosch X, Bodi V, Bellera N, Nunez J, Benito B, Ordonez J, Consuegra L, Heras M, Llecer 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. doi: 10.1136/hrt.2007.115626. Epub 2007 Jul 16.

  PMID: 17639094 BACKGROUND

• Sanchis J, Bosch X, Bodi V, Nunez J, Doltra A, Heras M, Mainar L, Santas E, Bragulat E, Garcia-Alvarez A, Carratala A, Llacer A. Randomized comparison between clinical evaluation plus N-terminal pro-B-type natriuretic peptide versus exercise testing for decision making in acute chest pain of uncertain origin. Am Heart J. 2010 Feb;159(2):176-82. doi: 10.1016/j.ahj.2009.11.010.

  PMID: 20152214 RESULT

MeSH Terms

Conditions

Chest Pain; Angina, Unstable

Interventions

Exercise Test; pro-brain natriuretic peptide (1-76)

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Juan Sanchis, MD

  Hospital Clínico Universitario. Valencia. Spain

  PRINCIPAL INVESTIGATOR

• Xavier Bosch, MD

  Hospital Clínic i Provincial. Barcelona. Spain

  STUDY CHAIR

• Angel Llácer, MD

  Hospital Clínico Universitario. Valencia. Spain.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 28, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: January 1, 2009
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)