Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients (IQSCINTIMYOC)

Cardiological examination is one of the major directions in nuclear medicine for detection of myocardial ischemia in patients with suspected coronary artery disease. In Caen, they constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4 minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To date, apart from the work on heart ghosts and one publication in abstract form in 2009, no other study have been published.

The goal of the study is to study the technical performance of the innovative technology IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: myocardial IQ-SPECT imaging applied to scintigraphic imaging; Device: scintigraphic imaging

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, CHU, France, 14000
    • Service Imagerie Médicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 18 years (except major patients under guardianship)
• free and informed consent signed
• written and spoken French
• beneficiaries of the social security system
• coronary insufficiency detection needed for patients with signs or symptoms suggestive of coronary insufficiency; or in symptomatic patients, but with a high risk of coronary heart disease: diabetes and / or with multiple cardiovascular risk factors and / or having a peripheral vascular disease

Exclusion Criteria:

• Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina);
• Patients with an irregular heartbeat, because of the impossibility of achieving a good quality ECG synchronization (atrial fibrillation, ventricular extra-systole or supraventricular over 25% of cardiac cycles);
• Patients with a pacemaker with a permanent electro-drive at rest;
• Patients with non-ischemic heart disease: primitive dilated cardiomyopathy, severe hypertrophic cardiomyopathy, severe valvular cardiomyopathy (aortic stenosis, aortic or mitral leakage grade> 2), congenital heart disease;
• Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment);
• Major patients under guardianship;
• Pregnant or lactating women;
• Women in age and condition of childbearing;
• Patients unable to understand the purpose of the study.

Cons-indications to physical stress test:

• Uncontrolled heart failure,
• Pulmonary embolism, phlebitis evolution,
• Myocarditis, pericarditis, endocarditis evolving
• Physical disability,
• Thrombus
• Asthma
• contra-indication for exercise testing as dipyridamole:
• Severe Asthma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Technology "IQ-SPECT" applied to myocardial imaging	Device: myocardial IQ-SPECT imaging applied to scintigraphic imaging; Device: scintigraphic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial perfusion binding	0 = normal fixing ≥70%; 1 = slightly reduced mounting 50-69%; 2 = moderately less attachment 30-49%; 3 = severely diminished attachment 10-20%; 4 = no binding <10%	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 13, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 10-030