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

Coronary Artery Disease Clinical Trial

— IQSCINTIMYOC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524600
• Other study ID #: 10-030
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: August 13, 2015
• Start date: January 2012

Study information

• Verified date: August 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• myocardial IQ-SPECT imaging applied to scintigraphic imaging

• scintigraphic imaging

Locations

Country	Name	City	State
France	Service Imagerie Médicale	Caen, CHU

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No