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

Coronary Artery Disease Clinical Trial

— FlowPromote  

Official title:

Influence of Intensive Lipid-lowering With Statin and Ezetimib Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain (The FLOW-PROMOTE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737408
• Other study ID #: Aarhus University Hospital
• Status: Recruiting
• Phase: Phase 3
• Start date: May 13, 2020
• Est. completion date: August 2023

Study information

• Verified date: February 2021
• Source: Aarhus University Hospital Skejby
• Contact: Bjarne L Noergaard, MD, PhD
• Phone: +4540136570
• Email: bnorgaard[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin 40mg
Rosuvastatin 40 mg

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Southwestern Hospital Esbjerg	Esbjerg
Denmark	Lillebaelt Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Bjarne Linde Noergaard

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reproducibility assessment	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.	9-months
Primary	18-month change in coronary flow	Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)	18 months
Secondary	18-month change high risk coronary plaque volumes	Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months)	18 months
Secondary	18-month change in high risk coronary plaque features	Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).	18-months
Secondary	18-month change in coronary vessel volumes	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-months
Secondary	18-month change in indices of coronary inflammation	Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months).	18-months