Prognostic Value of Myocardial Perfusion Heterogeneity in Normal SPECT Studies

Completed

• Conditions: Coronary Artery Disease; Coronary Atherosclerosis

• Registration Number: NCT02576704
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and should be managed with optimal medical treatment only.

Recently, new gamma cameras using semi-conductor detectors have been developed. Their diagnostic performances have been demonstrated and confronted with various anatomical and functional reference techniques, such as coronary angiography and FFR. The prognostic value of a normal SPECT MPI has not been specifically assessed yet.

Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of coronary artery disease (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.

Accordingly, the purpose of this study is :

* To assess the prognostic value of a normal myocardial perfusion stress imaging using a semiconductor gamma camera with a dual isotope high speed protocol,

* To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method, in normal SPECT MPIs.

The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.

Detailed Description

SPECT imaging protocol and analysis Stress tests and SPECTs are performed according to the routine protocols in use in our center. Briefly, at peak stress, patients were injected with thallium-201. Five to 10 minutes after stress, a 5-minutes supine acquisition was performed followed by a 5-minutes prone acquisition. Subsequently, technetium-99m-sestamibi was injected, and 2 minutes later a single 5-minutes rest acquisition was performed. During stress acquisition, patients were imaged in supine and prone positions with their arms positioned over their head. The rest acquisition was only acquired in supine position. The gated SPECT studies were performed at each acquisition. Injected activity (IA) was adjusted for patient weight. For weights of \<80 kg/ 80-100 kg/\>100 kg, thallium-201 IAs were 74/92/111 MBq and technetium-99m-sestamibi IAs were 300/370/450 MBq, respectively. A uniform imaging pre-treatment for the reconstruction of raw myocardial perfusion imaging data was applied, and images were reconstructed and reoriented to obtain transaxial sections of the left ventricle according to the three standard cardiac planes.

In this study, we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1119

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Breastfeeding women
• Myocardial perfusion abnormalities with SSS > 4

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome	3 years	number of cardiac death or nonfatal Myocardial Infarction

Secondary Outcome Measures

Name	Time	Method
fourth composite secondary outcome	3 years	number of all death or nonfatal Myocardial Infarction or stroke
first composite secondary outcome	3 years	number of cardiac death or nonfatal Myocardial Infarction or stroke
third composite secondary outcome	3 years	number of all death or nonfatal Myocardial Infarction
fifth composite secondary outcome	3 years	number of all death or nonfatal Myocardial Infarction or stroke or number of participants with myocardial revascularization
secondary composite secondary outcome	3 years	number of cardiac death or nonfatal Myocardial Infarction or stroke or number of participants with myocardial revascularization

Trial Locations

Locations (1)

Chu Grenoble; 🇫🇷 Grenoble, Isere, France