Ischemic Heart DiseaseMETSNCT02968771
Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT
An observational study of Ischemic Heart Disease, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Non intervention
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Jun 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prescription of cardiac perfusion SPECT
Who may be able to join
- Patients men or women ≥ 18 years of age
- Patients with prescription of cardiac perfusion SPECT
Who cannot join
- Patients with loss of consciousness or confuse, not able to read the information and to sign the writting consent
- Pregnant women
- Patients with dobutamine indications in the stress protocol
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.
Read the detailed description
The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.
- Conditions
- Ischemic Heart Disease
- Being tested
- Non intervention
- Keywords
- Coronary artery disease, Cardiac perfusion SPECT, Metabolomics
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with Physical Cardiac Stress | Patients with Physical Cardiac Stress Receives: Other: Non intervention | |
| Patients with Physical and Pharmacological Cardiac Stress | Patients with Physical and Pharmacological Cardiac Stress with adenosine agonist Receives: Other: Non intervention | |
| Patients with Pharmacological Cardiac Stress | Patients with Pharmacological Cardiac Stress with adenosine agonist Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.
Measured: 2 days
Metabolomic profile on NMR (Nuclear Magnetic Resonance ) analysis of serum sample
Once all samples analyzed, in order to identify of specific patterns associated to any group (type of test or result of test).
Measured: 6 month
Secondary outcomes (9)
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Measured: 1 year
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Measured: 3 years
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Measured: 5 years
Angina treatment initiation
Measured: 1 year
Angina treatment initiation
Measured: 3 years
Angina treatment initiation
Measured: 5 years
Metabolomic profile on NMR analysis of serum sample
Measured: 1 year
Metabolomic profile on NMR analysis of serum sample
Measured: 3 years
Metabolomic profile on NMR analysis of serum sample
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968771
- Sponsor's protocol ID
- METS
- Acronym
- METS
- Status last verified
- Feb 2019
- First submitted
- 16 Nov 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
PubMed 23996286Liga R, Vontobel J, Rovai D, Marinelli M, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Chiappino D, Marraccini P, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Filardi PP, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Stehli J, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Puzzuoli S, Mangione M, Marcheschi P, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Underwood SR, Knuuti J, Kaufmann PA, Neglia D, Gaemperli O; EVINCI Study Investigators. Multicentre multi-device hybrid imaging study of coronary artery disease: results from the EValuation of INtegrated Cardiac Imaging for the Detection and Characterization of Ischaemic Heart Disease (EVINCI) hybrid imaging population. Eur Heart J Cardiovasc Imaging. 2016 Sep;17(9):951-60. doi: 10.1093/ehjci/jew038. Epub 2016 Mar 18.
PubMed 26992419Mutuberria-Urdaniz M, Pizzi MN, Aguade-Bruix S, Candell-Riera J, Otaegui-Irurueta I. [Spastic coronary artery. Correlation of the myocardium at risk with scintigraphy and coronary angiography]. Rev Esp Med Nucl Imagen Mol. 2013 Jan;32(1):40-2. doi: 10.1016/j.remn.2011.12.004. Epub 2012 May 8. Spanish.
PubMed 23177343Weber KT. What can we learn from exercise testing beyond the detection of myocardial ischemia? Clin Cardiol. 1997 Aug;20(8):684-96. doi: 10.1002/clc.4960200805.
PubMed 9259161Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguade-Bruix S, Bermejo-Fraile B, Soler-Soler J. Dipyridamole administration at the end of an insufficient exercise Tc-99m MIBI SPECT improves detection of multivessel coronary artery disease in patients with previous myocardial infarction. Am J Cardiol. 2000 Mar 1;85(5):532-5. doi: 10.1016/s0002-9149(99)00806-1.
PubMed 11078262Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguade-Bruix S, Olona M, Palet J, Cortadellas J, Garcia-Burillo A, Soler-Soler J. Simultaneous dipyridamole/maximal subjective exercise with 99mTc-MIBI SPECT: improved diagnostic yield in coronary artery disease. J Am Coll Cardiol. 1997 Mar 1;29(3):531-6. doi: 10.1016/s0735-1097(96)00562-1.
PubMed 9060889Johnson SG, Peters S. Advances in pharmacologic stress agents: focus on regadenoson. J Nucl Med Technol. 2010 Sep;38(3):163-71. doi: 10.2967/jnmt.109.065581. Epub 2010 Aug 19.
PubMed 20724531Cassar A, Chareonthaitawee P, Rihal CS, Prasad A, Lennon RJ, Lerman LO, Lerman A. Lack of correlation between noninvasive stress tests and invasive coronary vasomotor dysfunction in patients with nonobstructive coronary artery disease. Circ Cardiovasc Interv. 2009 Jun;2(3):237-44. doi: 10.1161/CIRCINTERVENTIONS.108.841056. Epub 2009 May 8.
PubMed 20031721Rodriguez-Sinovas A, Sanchez JA, Gonzalez-Loyola A, Barba I, Morente M, Aguilar R, Agullo E, Miro-Casas E, Esquerda N, Ruiz-Meana M, Garcia-Dorado D. Effects of substitution of Cx43 by Cx32 on myocardial energy metabolism, tolerance to ischaemia and preconditioning protection. J Physiol. 2010 Apr 1;588(Pt 7):1139-51. doi: 10.1113/jphysiol.2009.186577. Epub 2010 Feb 15.
PubMed 20156849Caselli C, Rovai D, Lorenzoni V, Carpeggiani C, Teresinska A, Aguade S, Todiere G, Gimelli A, Schroeder S, Casolo G, Poddighe R, Pugliese F, Le Guludec D, Valente S, Sambuceti G, Perrone-Filardi P, Del Ry S, Marinelli M, Nekolla S, Pietila M, Lombardi M, Sicari R, Scholte A, Zamorano J, Kaufmann PA, Underwood SR, Knuuti J, Giannessi D, Neglia D; EVINCI Study Investigators. A New Integrated Clinical-Biohumoral Model to Predict Functionally Significant Coronary Artery Disease in Patients With Chronic Chest Pain. Can J Cardiol. 2015 Jun;31(6):709-16. doi: 10.1016/j.cjca.2015.01.035. Epub 2015 Feb 2.
PubMed 26022987Barba I, Jaimez-Auguets E, Rodriguez-Sinovas A, Garcia-Dorado D. 1H NMR-based metabolomic identification of at-risk areas after myocardial infarction in swine. MAGMA. 2007 Dec;20(5-6):265-71. doi: 10.1007/s10334-007-0097-8. Epub 2007 Dec 20.
PubMed 18095012Barba I, de Leon G, Martin E, Cuevas A, Aguade S, Candell-Riera J, Barrabes JA, Garcia-Dorado D. Nuclear magnetic resonance-based metabolomics predicts exercise-induced ischemia in patients with suspected coronary artery disease. Magn Reson Med. 2008 Jul;60(1):27-32. doi: 10.1002/mrm.21632.
PubMed 18581408
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT
- ClinicalTrials.gov ID
- NCT02968771
- Acronym / sponsor ID
- METS / METS
- Conditions
- Ischemic Heart Disease
- Keywords
- Coronary artery disease, Cardiac perfusion SPECT, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Nov 2016 (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 aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.
Detailed description
The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Physical Cardiac Stress | – | Other: Non interventionPatients with Physical Cardiac Stress |
| Patients with Physical and Pharmacological Cardiac Stress | – | Other: Non interventionPatients with Physical and Pharmacological Cardiac Stress with adenosine agonist |
| Patients with Pharmacological Cardiac Stress | – | Other: Non interventionPatients with Pharmacological Cardiac Stress with adenosine agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prescription of cardiac perfusion SPECT
Key inclusion criteria (2 listed)
- Patients men or women ≥ 18 years of age
- Patients with prescription of cardiac perfusion SPECT
Key exclusion criteria (3 listed)
- Patients with loss of consciousness or confuse, not able to read the information and to sign the writting consent
- Pregnant women
- Patients with dobutamine indications in the stress protocol
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 |
|---|---|---|
| Non intervention | Other | Patients with Pharmacological Cardiac Stress, Patients with Physical Cardiac Stress, Patients with Physical and Pharmacological Cardiac Stress |
Primary outcome
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.
Time frame: 2 days
Metabolomic profile on NMR (Nuclear Magnetic Resonance ) analysis of serum sample
Time frame: 6 month
Once all samples analyzed, in order to identify of specific patterns associated to any group (type of test or result of test).
9 secondary outcomes
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time frame: 1 year
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time frame: 3 years
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time frame: 5 years
Angina treatment initiation
Time frame: 1 year
Angina treatment initiation
Time frame: 3 years
Angina treatment initiation
Time frame: 5 years
Metabolomic profile on NMR analysis of serum sample
Time frame: 1 year
Metabolomic profile on NMR analysis of serum sample
Time frame: 3 years
Metabolomic profile on NMR analysis of serum sample
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Background: PubMed 23996286Task Force Members; Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabate M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines; Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Ryden L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. No abstract available.
- Background: PubMed 26992419Liga R, Vontobel J, Rovai D, Marinelli M, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Chiappino D, Marraccini P, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Filardi PP, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Stehli J, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Puzzuoli S, Mangione M, Marcheschi P, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Underwood SR, Knuuti J, Kaufmann PA, Neglia D, Gaemperli O; EVINCI Study Investigators. Multicentre multi-device hybrid imaging study of coronary artery disease: results from the EValuation of INtegrated Cardiac Imaging for the Detection and Characterization of Ischaemic Heart Disease (EVINCI) hybrid imaging population. Eur Heart J Cardiovasc Imaging. 2016 Sep;17(9):951-60. doi: 10.1093/ehjci/jew038. Epub 2016 Mar 18.
- Background: PubMed 23177343Mutuberria-Urdaniz M, Pizzi MN, Aguade-Bruix S, Candell-Riera J, Otaegui-Irurueta I. [Spastic coronary artery. Correlation of the myocardium at risk with scintigraphy and coronary angiography]. Rev Esp Med Nucl Imagen Mol. 2013 Jan;32(1):40-2. doi: 10.1016/j.remn.2011.12.004. Epub 2012 May 8. Spanish.
- Background: PubMed 9259161Weber KT. What can we learn from exercise testing beyond the detection of myocardial ischemia? Clin Cardiol. 1997 Aug;20(8):684-96. doi: 10.1002/clc.4960200805.
- Background: PubMed 11078262Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguade-Bruix S, Bermejo-Fraile B, Soler-Soler J. Dipyridamole administration at the end of an insufficient exercise Tc-99m MIBI SPECT improves detection of multivessel coronary artery disease in patients with previous myocardial infarction. Am J Cardiol. 2000 Mar 1;85(5):532-5. doi: 10.1016/s0002-9149(99)00806-1.
- Background: PubMed 9060889Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguade-Bruix S, Olona M, Palet J, Cortadellas J, Garcia-Burillo A, Soler-Soler J. Simultaneous dipyridamole/maximal subjective exercise with 99mTc-MIBI SPECT: improved diagnostic yield in coronary artery disease. J Am Coll Cardiol. 1997 Mar 1;29(3):531-6. doi: 10.1016/s0735-1097(96)00562-1.
- Background: PubMed 20724531Johnson SG, Peters S. Advances in pharmacologic stress agents: focus on regadenoson. J Nucl Med Technol. 2010 Sep;38(3):163-71. doi: 10.2967/jnmt.109.065581. Epub 2010 Aug 19.
- Background: PubMed 20031721Cassar A, Chareonthaitawee P, Rihal CS, Prasad A, Lennon RJ, Lerman LO, Lerman A. Lack of correlation between noninvasive stress tests and invasive coronary vasomotor dysfunction in patients with nonobstructive coronary artery disease. Circ Cardiovasc Interv. 2009 Jun;2(3):237-44. doi: 10.1161/CIRCINTERVENTIONS.108.841056. Epub 2009 May 8.
- Background: PubMed 20156849Rodriguez-Sinovas A, Sanchez JA, Gonzalez-Loyola A, Barba I, Morente M, Aguilar R, Agullo E, Miro-Casas E, Esquerda N, Ruiz-Meana M, Garcia-Dorado D. Effects of substitution of Cx43 by Cx32 on myocardial energy metabolism, tolerance to ischaemia and preconditioning protection. J Physiol. 2010 Apr 1;588(Pt 7):1139-51. doi: 10.1113/jphysiol.2009.186577. Epub 2010 Feb 15.
- Background: PubMed 26022987Caselli C, Rovai D, Lorenzoni V, Carpeggiani C, Teresinska A, Aguade S, Todiere G, Gimelli A, Schroeder S, Casolo G, Poddighe R, Pugliese F, Le Guludec D, Valente S, Sambuceti G, Perrone-Filardi P, Del Ry S, Marinelli M, Nekolla S, Pietila M, Lombardi M, Sicari R, Scholte A, Zamorano J, Kaufmann PA, Underwood SR, Knuuti J, Giannessi D, Neglia D; EVINCI Study Investigators. A New Integrated Clinical-Biohumoral Model to Predict Functionally Significant Coronary Artery Disease in Patients With Chronic Chest Pain. Can J Cardiol. 2015 Jun;31(6):709-16. doi: 10.1016/j.cjca.2015.01.035. Epub 2015 Feb 2.
- Background: PubMed 18095012Barba I, Jaimez-Auguets E, Rodriguez-Sinovas A, Garcia-Dorado D. 1H NMR-based metabolomic identification of at-risk areas after myocardial infarction in swine. MAGMA. 2007 Dec;20(5-6):265-71. doi: 10.1007/s10334-007-0097-8. Epub 2007 Dec 20.
- Background: PubMed 18581408Barba I, de Leon G, Martin E, Cuevas A, Aguade S, Candell-Riera J, Barrabes JA, Garcia-Dorado D. Nuclear magnetic resonance-based metabolomics predicts exercise-induced ischemia in patients with suspected coronary artery disease. Magn Reson Med. 2008 Jul;60(1):27-32. doi: 10.1002/mrm.21632.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by Hospital Universitari Vall d'Hebron Research Institute 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2019. 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?
Results are not available in the source record.
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?
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect. (time frame: 2 days). The study lists 2 primary outcomes in all. 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 NCT02968771, which also lists 12 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 25 Feb 2019.