Clinical trial NCT04737408: Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery disease, fractional flow reserve
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 18-month change in coronary flow
timeFrame: 18 months
Secondary outcomes:
measure: 18-month change high risk coronary plaque volumes
timeFrame: 18 months
measure: 18-month change in high risk coronary plaque features
timeFrame: 18-months
measure: 18-month change in coronary vessel volumes
timeFrame: 18-months
measure: 18-month change in indices of coronary inflammation
timeFrame: 18-months
Other outcomes:
measure: Reproducibility assessment
timeFrame: 9-months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Esbjerg
country: Denmark
facility: Southwestern Hospital Esbjerg
city: Vejle
country: Denmark
facility: Lillebaelt Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Bjarne L Noergaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: