Coronary Artery Disease
Conditions
Keywords
fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, statin, blood cholesterol level
Brief summary
This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Detailed description
Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol \>2 mM), and at least one translesional FFRct value \<0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either atorvastatin 40 mg daily or rosuvastatin 40 mg + ezetimibe 10 mg daily treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.
Interventions
DRUGHigh intensity lipid lowering
Two different regimens of drugs with different effects on LDL lowering
Sponsors
HeartFlow, Inc.
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥35 y * Symptoms suggestive of stable CAD * No pre-CTA known CAD * At least one lesion with FFRct \<0.81 * Sinus rhythm * LDL cholesterol \>2.0 mM * Statin use \>2 months * Life expentancy \< 3 years * Signed informed consent
Exclusion criteria
* Known CAD * Poor CTA image quality inadequiate for FFRct analysis (determined by corelab) * Significant CAD in the left main or proximal coronary segments * Referral to invasive catheterization * Statin intolerance * BMI \>40 * Allergy to ionidated contrast * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in FFRct values | 18 months | CT derived FFR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in FFRct values | 9 months | CT derived FFR |
| Changes in low density plaque volumes | 0-9, and 0-18 months | CT determined plaque volumes |
Countries
Denmark
Outcome results
None listed