Coronary Artery Disease
Conditions
Keywords
coronary artery disease, fractional flow reserve
Brief summary
The FLOW-PROMOTE Study is an investigator-initiated, Danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by CT derived fractional flow reserve (FFRCT).
Detailed description
Multicenter study (4 centers in Denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by FFRCT. By using two lipid lowering treatment strategies (usual vs intensive care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated CT angiograms with plaque and FFRCT analyses at 9 and 18 months.
Interventions
Rosuvastatin 40 mg
Sponsors
Bjarne Linde Noergaard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open label design
Intervention model description
Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptoms suggestive of stable coronary artery disease (CAD) 2. No known CAD 3. At least one coronary stenosis with \>49% lumen reduction determined by CT angiography 4. Sinus rhythm 5. At least one lesion with FFRCT \<0.81 (see below) 6. Life expectancy \>3 years 7. Fertile women must use safe contraception throughout the study period 8. Signed informed consent 5\. LDL cholesterol \>2.0 mM (patients already on lipid lowering medical therapy \< 3 months can be included if meeting all of the above mentioned criteria)
Exclusion criteria
1. Unstable angina 2. Known CAD 3. Body mass index \>40 4. Allergy to iodinated contrast media 5. Known statin intolerance 6. Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory) 7. Significant left main coronary artery (stenosis \>49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA 8. FFRCT \<0.81 over the left main coronary artery or the proximal left anterior descendens artery (LAD) segment, or \<0.76 over the mid-LAD, proximal circumflex, right coronary artery or intermediate coronary segments 9. Pregnancy (women with age \>45 will be screened for pregnancy) 10. Moderate to severe liver failure 11. Estimated glomerular filtration rate (eGFR) \< 60 ml/min 12. Participation in another trial 13. Does noes not wish to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18-month change in coronary flow | 18 months | Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18-month change high risk coronary plaque volumes | 18 months | Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months) |
| 18-month change in high risk coronary plaque features | 18-months | Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months). |
| 18-month change in coronary vessel volumes | 18-months | Will be assessed by calculating the vessel volume relative to myocardial mass (V/M) ratio determined from repetitive CT angiograms (0,9, and 18 months). |
| 18-month change in indices of coronary inflammation | 18-months | Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility assessment | 9-months | There will be performed 2 CTA investigations at the 9 month follow-up. Reproducibility assessment of CT derived FFR, plaque markers, FAI and V/M ratio will be performed by calculation of standard error of measurement and within-subject coefficient of variation. |
Countries
Denmark
Contacts
Primary ContactBjarne L Noergaard, MD, PhD
Backup ContactMartin B Mortensen, MD, PhD
Outcome results
None listed