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OpenTrials
Completed

NCT Number: NCT02524600

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

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Imagerie Médicale

Caen, CHU, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

myocardial IQ-SPECT imaging applied to scintigraphic imaging

Device

scintigraphic imaging

Device

Primary outcomes

  1. Myocardial perfusion binding

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: IQSCINTIMYOC

Important dates

Study start
2012
Primary completion
2012
First posted
Aug 17, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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