Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients (IQSCINTIMYOC)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
myocardial IQ-SPECT imaging applied to scintigraphic imaging
scintigraphic imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Service Imagerie Médicale
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
New Technology "IQ-SPECT" applied to myocardial imaging
Arm Description
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
Full Information
NCT ID
NCT02524600
First Posted
August 5, 2015
Last Updated
August 13, 2015
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02524600
Brief Title
Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients
Acronym
IQSCINTIMYOC
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
New Technology "IQ-SPECT" applied to myocardial imaging
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
myocardial IQ-SPECT imaging applied to scintigraphic imaging
Intervention Type
Device
Intervention Name(s)
scintigraphic imaging
Primary Outcome Measure Information:
Title
Myocardial perfusion binding
Description
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%
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service Imagerie Médicale
City
Caen, CHU
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients
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