Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

Ischemic Heart Disease Clinical Trial

— METS  

Official title:

Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02968771
• Other study ID #: METS
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: June 2022

Study information

• Verified date: February 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: June 2022
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients men or women = 18 years of age

• Patients with prescription of cardiac perfusion SPECT

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Non intervention

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d`Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Barba I, de León G, Martín E, Cuevas A, Aguade S, Candell-Riera J, Barrabés 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. — View Citation

Barba 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. Epub 2007 Dec 20. — View Citation

Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguadé-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. — View Citation

Candell-Riera J, Santana-Boado C, Castell-Conesa J, Aguadé-Bruix S, Olona M, Palet J, Cortadellas J, García-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. — View Citation

Caselli 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. — View Citation

Cassar 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. — View Citation

Johnson 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. Review. — View Citation

Liga R, Vontobel J, Rovai D, Marinelli M, Caselli C, Pietila M, Teresinska A, Aguadé-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, Fernández-Golfín C, Rincón LM, Graner FP, de Graaf MA, Stehli J, Reyes E, Nkomo S, Mäki 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. — View Citation

Mutuberria-Urdániz M, Pizzi MN, Aguadé-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. — View Citation

Rodríguez-Sinovas A, Sánchez JA, González-Loyola A, Barba I, Morente M, Aguilar R, Agulló E, Miró-Casas E, Esquerda N, Ruiz-Meana M, García-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. — View Citation

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, Sabaté 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, Rydén 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. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1. — View Citation

Weber KT. What can we learn from exercise testing beyond the detection of myocardial ischemia? Clin Cardiol. 1997 Aug;20(8):684-96. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.		2 days
Primary	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).	6 month
Secondary	Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.		1 year
Secondary	Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.		3 years
Secondary	Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.		5 years
Secondary	Angina treatment initiation		1 year
Secondary	Angina treatment initiation		3 years
Secondary	Angina treatment initiation		5 years
Secondary	Metabolomic profile on NMR analysis of serum sample		1 year
Secondary	Metabolomic profile on NMR analysis of serum sample		3 years
Secondary	Metabolomic profile on NMR analysis of serum sample		5 years