coronary artery disease
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We propose a study to evaluate the clinical significance of MSCT-CA and SPECT fusion imaging. To decide whether the new diagnostic strategy should actually replace the current strategy a study that evaluates the effect on decision making is needed. Since it is unethical to perform a randomized controlled trial to evaluate the new diagnostic process we compare the hypothetical therapeutic decisions by a panel of cardiologists, a cardio-thoracic surgeon, a radiologist and a nuclear medicine physician. The primary endpoint of this study will be the therapeutic modalities indicated by the routine *heart team* and the panel evaluations. The panel will decide in each patient among three strategies: i. No action taken other than therapeutic advice and/or additional medication, or ii. Revascularization by percutaneous coronary intervention (PCI), or iii. Revascularization by coronary artery bypass grafting (CABG). Two secondary endpoints have been defined for this study. 1. The performance of the MSCT-CA and SPECT scan images in diagnosing hemodynamically significant coronary artery disease will be determined versus the gold standard, invasive coronary angiography. 2. The additive value of fusion images of the MSCT-CA and SPECT by direct overlay technique will be evaluated for their incremental value in diagnosing hemodynamically significant coronary artery disease versus separate MSCT-CA and SPECT images. | — |
Secondary
| Measure | Time frame |
|---|---|
| Two secondary endpoints have been defined for this study. 1. The performance of the MSCT-CA and SPECT scan images in diagnosing hemodynamically significant coronary artery disease will be determined versus the gold standard, invasive coronary angiography. 2. The additive value of fusion images of the MSCT-CA and SPECT by direct overlay technique will be evaluated for their incremental value in diagnosing hemodynamically significant coronary artery disease versus separate MSCT-CA and SPECT images. | — |
Countries
Netherlands
Outcome results
None listed