Status:
UNKNOWN
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
Lead Sponsor:
Bjarne Linde Noergaard
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 f...
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 treatm...
Eligibility Criteria
Inclusion
- Symptoms suggestive of stable coronary artery disease (CAD)
- No known CAD
- At least one coronary stenosis with \>49% lumen reduction determined by CT angiography
- Sinus rhythm
- At least one lesion with FFRCT \<0.81 (see below)
- Life expectancy \>3 years
- Fertile women must use safe contraception throughout the study period
- 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
- Unstable angina
- Known CAD
- Body mass index \>40
- Allergy to iodinated contrast media
- Known statin intolerance
- Poor coronary CT angiography image quality inadequate for FFRCT calculation (determined by core-laboratory)
- Significant left main coronary artery (stenosis \>49%) or three-vessel CAD determined by coronary CT angiography leading to direct referral to ICA
- 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
- Pregnancy (women with age \>45 will be screened for pregnancy)
- Moderate to severe liver failure
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min
- Participation in another trial
- Does noes not wish to participate
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04737408
Start Date
May 13 2020
End Date
August 1 2023
Last Update
February 5 2021
Active Locations (3)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200 N
2
Southwestern Hospital Esbjerg
Esbjerg, Denmark, 6700
3
Lillebaelt Hospital
Vejle, Denmark, 7100