N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
Primary Purpose
Chest Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise testing
Clinical evaluation + NTproBNP
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain focused on measuring Chest pain, Unstable angina, NT-proBNP, Exercise test.
Eligibility Criteria
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.
Sites / Locations
- Hospital Clínico Universitario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Discharge if clinical risk score <3 points + Nt-proBNP <110 ng/L
Discharge if negative exercise testing
Outcomes
Primary Outcome Measures
Hospitalization
Secondary Outcome Measures
Death, myocardial infarction
Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina
Full Information
NCT ID
NCT00493844
First Posted
June 26, 2007
Last Updated
October 24, 2016
Sponsor
University of Valencia
Collaborators
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00493844
Brief Title
N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Chest pain, Unstable angina, NT-proBNP, Exercise test.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Discharge if clinical risk score <3 points + Nt-proBNP <110 ng/L
Arm Title
2
Arm Type
Active Comparator
Arm Description
Discharge if negative exercise testing
Intervention Type
Other
Intervention Name(s)
Exercise testing
Intervention Description
Exercise testing
Intervention Type
Other
Intervention Name(s)
Clinical evaluation + NTproBNP
Intervention Description
Clinical evaluation + NTproBNP levels
Primary Outcome Measure Information:
Title
Hospitalization
Time Frame
At the index episode (1 day)
Secondary Outcome Measure Information:
Title
Death, myocardial infarction
Time Frame
6-12 months
Title
Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina
Time Frame
6-12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Sanchis, MD
Organizational Affiliation
Hospital Clínico Universitario. Valencia. Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier Bosch, MD
Organizational Affiliation
Hospital Clínic i Provincial. Barcelona. Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angel Llácer, MD
Organizational Affiliation
Hospital Clínico Universitario. Valencia. Spain.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16053956
Citation
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.
Results Reference
background
PubMed Identifier
16490427
Citation
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.
Results Reference
background
PubMed Identifier
17350368
Citation
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.
Results Reference
background
PubMed Identifier
17639094
Citation
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.
Results Reference
background
PubMed Identifier
20152214
Citation
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.
Results Reference
result
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N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
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