Chest PainNCT00493844
N-terminal Pro B-type Natriuretic Peptide (Nt-proBNP) Versus Exercise Test for Evaluation of Acute Chest Pain
A study testing Exercise testing and Clinical evaluation + NTproBNP in people with Chest Pain, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Pain
- What is being tested?
- Exercise testing and Clinical evaluation + NTproBNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chest pain of possible coronary origin at criterion of cardiology on duty
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chest Pain
- Being tested
- Exercise testing, Clinical evaluation + NTproBNP
- Keywords
- Chest pain, Unstable angina, NT-proBNP, Exercise test.
- Medical subject headings
- Chest Pain, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testingOther
Exercise testing
Clinical evaluation + NTproBNPOther
Clinical evaluation + NTproBNP levels
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Discharge if clinical risk score <3 points + Nt-proBNP <110 ng/L Receives: Other: Clinical evaluation + NTproBNP |
| 2 | Active comparator | Discharge if negative exercise testing Receives: Other: Exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
Measured: At the index episode (1 day)
Secondary outcomes (2)
Death, myocardial infarction
Measured: 6-12 months
Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Juan Sanchis, University of Valencia
- Investigators
- Juan Sanchis, MD, Principal investigator, Hospital Clínico Universitario. Valencia. SpainXavier Bosch, MD, Study chair, Hospital Clínic i Provincial. Barcelona. SpainAngel Llácer, MD, Study director, Hospital Clínico Universitario. Valencia. Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493844
- Sponsor's protocol ID
- 09-27-06
- Status last verified
- Oct 2016
- First submitted
- 26 Jun 2007
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16053956Sanchis 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.
PubMed 16490427Sanchis 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.
PubMed 17350368Sanchis 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.
PubMed 17639094Sanchis 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.
PubMed 20152214
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00493844
- Acronym / sponsor ID
- 09-27-06
- Conditions
- Chest Pain
- Keywords
- Chest pain, Unstable angina, NT-proBNP, Exercise test.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Clinical evaluation + NTproBNPDischarge if clinical risk score <3 points + Nt-proBNP <110 ng/L |
| 2 | Active comparator | Other: Exercise testingDischarge if negative exercise testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chest pain of possible coronary origin at criterion of cardiology on duty
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise testingExercise testing | Other | 2 |
| Clinical evaluation + NTproBNPClinical evaluation + NTproBNP levels | Other | 1 |
Primary outcome
Hospitalization
Time frame: At the index episode (1 day)
2 secondary outcomes
Death, myocardial infarction
Time frame: 6-12 months
Death, myocardial infarction, postdischarge revascularization or readmission by unstable angina
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 16053956Sanchis 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.
- Background: PubMed 16490427Sanchis 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.
- Background: PubMed 17350368Sanchis 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.
- Background: PubMed 17639094Sanchis 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 publication: PubMed 20152214Sanchis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Sanchis, MD principal investigator
Hospital Clínico Universitario. Valencia. Spain
Xavier Bosch, MD study chair
Hospital Clínic i Provincial. Barcelona. Spain
Angel Llácer, MD study director
Hospital Clínico Universitario. Valencia. Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise testing and Clinical evaluation + NTproBNP in people with Chest Pain, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: At the index episode (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493844, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.