N-Terminal Pro B-Type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
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First Received Date ICMJE | June 26, 2007 | ||||||||||||
Last Updated Date | January 27, 2009 | ||||||||||||
Start Date ICMJE | January 2007 | ||||||||||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Hospitalization [ Time Frame: At the index episode (1 day) ] [ Designated as safety issue: Yes ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Hospitalisation [ Time Frame: Index episode ] | ||||||||||||
Change History | Complete list of historical versions of study NCT00493844 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | N-Terminal Pro B-Type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain | ||||||||||||
Official Title ICMJE | 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 | ||||||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | |||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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Condition ICMJE | Chest Pain | ||||||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Enrollment ICMJE | 320 | ||||||||||||
Completion Date | January 2009 | ||||||||||||
Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | |||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Location Countries ICMJE | Spain | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00493844 | ||||||||||||
Other Study ID Numbers ICMJE | 09-27-06 | ||||||||||||
Has Data Monitoring Committee | No | ||||||||||||
Responsible Party | Juan Sanchis Forés, Hospital Clínico Valenia | ||||||||||||
Study Sponsor ICMJE | University of Valencia | ||||||||||||
Collaborators ICMJE | Hospital Clinic of Barcelona | ||||||||||||
Investigators ICMJE |
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Information Provided By | University of Valencia | ||||||||||||
Verification Date | January 2009 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |