Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

NCT02968771 | Unknown

• 1 other identifier: METS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Heart Disease

Keywords

Coronary artery disease; Cardiac perfusion SPECT; Metabolomics

Outcome Measures

Primary Outcomes (2)

• Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.

  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).

  6 month

Secondary Outcomes (9)

• Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.

  1 year

• Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.

  3 years

• Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.

  5 years

• Angina treatment initiation

  1 year

• Angina treatment initiation

  3 years

Study Arms (3)

Patients with Physical Cardiac Stress

Patients with Physical Cardiac Stress

Other: Non intervention

Patients with Physical and Pharmacological Cardiac Stress

Patients with Physical and Pharmacological Cardiac Stress with adenosine agonist

Other: Non intervention

Patients with Pharmacological Cardiac Stress

Patients with Pharmacological Cardiac Stress with adenosine agonist

Other: Non intervention

Interventions

Non intervention OTHER

Patients with Pharmacological Cardiac Stress; Patients with Physical Cardiac Stress; Patients with Physical and Pharmacological Cardiac Stress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with prescription of cardiac perfusion SPECT

You may qualify if:

• Patients men or women ≥ 18 years of age
• Patients with prescription of cardiac perfusion SPECT

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (12)

• 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.

  PMID: 23996286 BACKGROUND

• Liga 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.

  PMID: 26992419 BACKGROUND

• Mutuberria-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.

  PMID: 23177343 BACKGROUND

• Weber 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.

  PMID: 9259161 BACKGROUND

• Candell-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.

  PMID: 11078262 BACKGROUND

• Candell-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.

  PMID: 9060889 BACKGROUND

• 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.

  PMID: 20724531 BACKGROUND

• 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.

  PMID: 20031721 BACKGROUND

• Rodriguez-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.

  PMID: 20156849 BACKGROUND

• 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.

  PMID: 26022987 BACKGROUND

• 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. doi: 10.1007/s10334-007-0097-8. Epub 2007 Dec 20.

  PMID: 18095012 BACKGROUND

• Barba 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.

  PMID: 18581408 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples without DNA

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2022
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)