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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 5, 2015
Last Updated
August 13, 2015
Sponsor
University Hospital, Caen
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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

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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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