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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: myocardial IQ-SPECT imaging applied to scintigraphic imaging; Device: scintigraphic imaging

• Registration Number: NCT02524600
• Lead Sponsor: University Hospital, Caen

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New Technology "IQ-SPECT" applied to myocardial imaging	scintigraphic imaging	-
New Technology "IQ-SPECT" applied to myocardial imaging	myocardial IQ-SPECT imaging applied to scintigraphic imaging	-

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion binding	baseline	* 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%

Trial Locations

Locations (1)

Service Imagerie Médicale; 🇫🇷 Caen, CHU, France