Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women

NCT01679886 | Completed

• 1 other identifier: AOM 11066
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study will be to compare the diagnostic performances of 82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of myocardial ischemia in a population of overweighed patients on one hand, and women on the other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the DIAMOND-FORRESTER score in symptomatic patients).

Conditions

Myocardial Ischemia

Keywords

Position emission tomography;; Rubidium;; Women;; Overweighted patients

Outcome Measures

Primary Outcomes (1)

• Myocardial ischemia

  Patients will be classified as positive in case of: * Coronary stenosis ≥ 50 % on coronary angiography and fractional flow reserve \< 0.8, or, in absence of FFR, a critical coronary stenosis. * In absence of coronary angiography, presence of cardiovascular event during the following year.

  1 year

Secondary Outcomes (1)

• Size and intensity of myocardial ischemia

  1 year

Study Arms (1)

Rubidium PET

EXPERIMENTAL

Rubidium PET

Radiation: Rubidium PET

Interventions

Rubidium PET RADIATION

Rubidium PET

Rubidium PET

Eligibility Criteria

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

You may qualify if:

• Overweighed (body mass index ≥ 25) or women addressed in the Department of Nuclear Medicine for diagnostic cardiac scintigraphy with an intermediate pre-test prevalence of CAD (≥ 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the DIAMOND-FORRESTER score in symptomatic patients).

You may not qualify if:

• Pregnant women;
• Contraindication to dipyridamole injection.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier Bichat - Claude Bernard

Paris, Île-de-France Region, 75018, France

Location

Related Publications (2)

• Sprauel T, Imbert L, Doyeux K, Perrin M, Claudin M, Roch V, Doyen M, Roth N, Lamash Y, Chequer R, Rouzet F, Hyafil F, Marie PY. Assessment of sestamibi CZT-SPECT reconstructed using deep-learning-based virtual attenuation correction maps according to coronary artery territory and with comparison to rubidium-PET. J Nucl Cardiol. 2025 Jul;49:102226. doi: 10.1016/j.nuclcard.2025.102226. Epub 2025 Apr 19.

  PMID: 40258438 DERIVED

• Mimouni M, Bulsei J, Darlington M, Estellat C, Rouzet F, Hyafil F, Durand-Zaleski I; RUBIS Trial Group. Cost-effectiveness of 82-Rubidium PET myocardial perfusion imaging for the diagnosis of myocardial ischemia depending on the prevalence of coronary artery disease. EJNMMI Res. 2023 Feb 8;13(1):9. doi: 10.1186/s13550-023-00954-x.

  PMID: 36752899 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dominique LE GULUDEC, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  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: September 3, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2016-06

Locations

FR (1)