NCT02524600

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 .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

August 5, 2015

Last Update Submit

August 13, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

New Technology "IQ-SPECT" applied to myocardial imaging

EXPERIMENTAL
Device: myocardial IQ-SPECT imaging applied to scintigraphic imagingDevice: scintigraphic imaging

Interventions

myocardial IQ-SPECT imaging applied to scintigraphic imagingDEVICE
New Technology "IQ-SPECT" applied to myocardial imaging
scintigraphic imagingDEVICE
New Technology "IQ-SPECT" applied to myocardial imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Imagerie Médicale

Caen, CHU, 14000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 17, 2015

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

FR(1)