Relation between plaque characteristics and hemodynamic significance of coronary lesions

Withdrawn

Conditions: atherosclerose
coronary plaques
10011082

Registration Number: NL-OMON39675

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- patients scheduled for coronary angiography (CAG)in combination with fractional flow reserve (FFR)/ coronary flow reserve (CFR) measurements
- 18 years or older
- signed, written informed consent
- informed consent for study 11-464

Exclusion Criteria

- acute coronary syndrome
- atrial fibrillation
- previous coronary bypass graft surgery
- previous myocardial infarction
- impaired left ventricular (LV) function (ejection fraction < 40%),
- obstructive pulmonary disease
- pregnancy or possible pregnancy
- lactation
- documented allergic reaction to gadolinium or iopromide
The same as is study 11-464:
- subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2)
- impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>On the CCTA images the presence of calcified, mixed and non-calcified plaques<br /><br>will be assessed. FFR and CFR will be measured in all vessels with 40-70%<br /><br>stenosis. FFR < 0.80 and CFR < 2.0 will be considered hemodynamically<br /><br>significant.<br /><br>To assess the presence of TCFA all patients will undergo an additional IVOCT of<br /><br>approximately 15 minutes during the heart catheterisation. IVOCT-TCFA will be<br /><br>defined as an IVOCT-delineated necrotic core with an overlying fibrous cap<br /><br>where the thickness of the fibrous cap is less than 65 µm.</p><br>

Secondary Outcome Measures