Back to resultsInfluence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study) (FlowPromote)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Rosuvastatin 40mg
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary artery disease, fractional flow reserve
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Aarhus University HospitalRecruiting
- Southwestern Hospital EsbjergRecruiting
- Lillebaelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
"Usual care"
"Intensive care"
Arm Description
"Usual care" prevention: atorvastatin 40 mg per day for 18 months
"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months
Outcomes
Primary Outcome Measures
18-month change in coronary flow
Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)
Secondary Outcome Measures
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-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-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-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).
Full Information
NCT ID
NCT04737408
First Posted
January 28, 2021
Last Updated
February 3, 2021
Sponsor
Bjarne Linde Noergaard
1. Study Identification
Unique Protocol Identification Number
NCT04737408
Brief Title
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bjarne Linde Noergaard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, fractional flow reserve
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized 1:1 to two different lipid lowering medical treatment strategies
Masking
None (Open Label)
Masking Description
Open label design
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Usual care"
Arm Type
Active Comparator
Arm Description
"Usual care" prevention: atorvastatin 40 mg per day for 18 months
Arm Title
"Intensive care"
Arm Type
Experimental
Arm Description
"Intensive care" prevention: rosuvastatin 40 mg + ezetimib 10 mg per day for 18 months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 40mg
Other Intervention Name(s)
Ezetimib 10mg
Intervention Description
Rosuvastatin 40 mg
Primary Outcome Measure Information:
Title
18-month change in coronary flow
Description
Coronary flow will be assessed by repetitive FFRCT assessments (0,9 and 18 months)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
18-month change high risk coronary plaque volumes
Description
Will be assessed by measuring low attenuation coronary plaque (LAP) volumes at repetitive CT angiograms (0,9, and 18 months)
Time Frame
18 months
Title
18-month change in high risk coronary plaque features
Description
Will be assessed by quantifying the proportion of lesions with positive remodeling at repetitive CT angiograms (0,9, and 18 months).
Time Frame
18-months
Title
18-month change in coronary vessel volumes
Description
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).
Time Frame
18-months
Title
18-month change in indices of coronary inflammation
Description
Will be assessed by the pericoronary fat attenuation index (FAI) determined from repetitive CT angiograms (0,9, and 18 months).
Time Frame
18-months
Other Pre-specified Outcome Measures:
Title
Reproducibility assessment
Description
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.
Time Frame
9-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bjarne L Noergaard, MD, PhD
Phone
+4540136570
Email
bnorgaard@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Martin B Mortensen, MD, PhD
Phone
+4523882155
Email
martin.bodtker.mortensen@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjarne L Noergaard, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200 N
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjarne L Noergaard, MD, PhD
Phone
+4540136570
Email
bnorgaard@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Martin B Mortensen, MD, PhD
Phone
+4523882155
Email
martin.bodtker.mortensen@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Jesper M Jensen, MD, PhD
Facility Name
Southwestern Hospital Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels-Peter R Sand, MD, PhD
Phone
+4528409148
Email
npsand@webspeed.dk
First Name & Middle Initial & Last Name & Degree
Lone D Kristensen, MD
Phone
+4521422813
Email
lone.dejbjerg@dadlnet.dk
Facility Name
Lillebaelt Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Busk, MD, PhD
Phone
+4522473224
Email
martin.busk@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Flemming H Steffensen, MD, PhD
Phone
+4551503862
Email
flemming.hald@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Intensive Lipid-lowering on FFRCT (The FLOW-PROMOTE Study)
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