Prognostic Value of SPECT-imaging Myocardial Perfusion Heterogeneity

NCT02208765 | Unknown DMC

• 1 other identifier: 38RC13.723
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known CAD. Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown. More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested. Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT. The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease. The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD. The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.

Conditions

Coronary Artery Disease; Coronary Atherosclerosis

Keywords

Coronary Circulation; Coronary Artery Disease; Myocardial perfusion imaging; Prognosis

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac and Cerebrovascular Events (MACCEs)

  Composite outcome : cardiac death and/or acute coronary syndrome and/or coronary artery bypass graft and/or percutaneous coronary intervention and/or stroke and/or symptomatic peripheral artery disease

  2 years

Secondary Outcomes (15)

• composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction

  2 years

• composite secondary outcome : number of cardiac death or nonfatal Myocardial Infarction or stroke

  2 years

• composite secondary outcome : number of participants with myocardial revascularization

  2 years

• composite secondary outcome : number of all death or non fatal Myocardial Infarction

  2 years

• composite secondary outcome : number of all death or non fatal Myocardial Infarction or non fatal stroke

  2 years

Study Arms (1)

Study cohort

OTHER

Any patient referred to the Nuclear Cardiology Laboratory of the University Hospital of Grenoble for myocardial perfusion imaging for diagnosis or prognosis evaluation of suspected or know coronary artery disease

Device: Stress Single Photon Emission Computed Tomography

Interventions

Stress Single Photon Emission Computed Tomography DEVICE

Study cohort

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Clinical indication for myocardial perfusion imaging

You may not qualify if:

• Pregnancy
• Breast feeding women
• Severe comorbidity with life expectancy 6 months
• Left bundle branch block on ECG making heteogeneity analysis impossible
• Patient not resident in the Rhône-Alpes region

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

Related Publications (4)

• Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.

  PMID: 14581384 BACKGROUND

• Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12. doi: 10.1016/j.jacc.2005.01.040.

  PMID: 15862426 BACKGROUND

• Vanzetto G, Ormezzano O, Fagret D, Comet M, Denis B, Machecourt J. Long-term additive prognostic value of thallium-201 myocardial perfusion imaging over clinical and exercise stress test in low to intermediate risk patients : study in 1137 patients with 6-year follow-up. Circulation. 1999 Oct 5;100(14):1521-7. doi: 10.1161/01.cir.100.14.1521.

  PMID: 10510055 BACKGROUND

• Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.

  PMID: 16157524 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Gerald Vanzetto, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

FR (1)