Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bjarne Linde Noergaard
• Treatments: Rosuvastatin Calcium

Criteria

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