- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02524600
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 .
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Caen, CHU, Frankrike, 14000
- Service Imagerie Médicale
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: New Technology "IQ-SPECT" applied to myocardial imaging
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Myocardial perfusion binding
Tidsram: baseline
|
|
baseline
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-030
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