MedPath

High and intermediate risk SPECT-CT optimization study

Completed
Conditions
coronary artery disease
10011082
10003216
Registration Number
NL-OMON33985
Lead Sponsor
Sint Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
400
Inclusion Criteria

a. The subject is a man and is 45 years of age or older in case of no known history of CAD and 18 years of age or older if the subject has a history of CAD. Or the subject is a woman and 45 years of age or older, in case of a known history of CAD and if the subject has no history of CAD.
b. Written informed consent is obtained.
c. The subject has the clinical suspicion of having (recurrent) angina pectoris or an equivalent, based on history taking, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests).
d. The subject has an intermediate or high risk of suffering from symptomatic coronary artery disease based on the combined Diamond and Forrester and CASS data. Using cutoff values of <13%, >87% and in between for low, high and intermediate risk of coronary artery disease respectively.
e. The patient has a history of percutaneous coronary intervention or coronary artery bypass grafting.

Exclusion Criteria

a. The subject is suffering from unstable angina pectoris.
b. The subject is suffering from decompensated congestive cardiac failure.
c. The subject is suffering from a known non-ischemic cardiomyopathy
d. The subject is suffering from a cardiac rhythm other than sinus rhythm.
e. The subject is or might be pregnant.
f. The subject is morbidly obese (BMI > 40).
g. The subject is not able to sustain a breath-hold for 25 seconds.
h. The subject is unable to remain in supine position for at least 30 minutes.
i. The subject has known allergies to or contra-indications to receiving an iodinated contrast agent.
j. Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.
k. There is a severe language barrier.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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