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Influence of Lipid Lowering on Impaired Coronary Flow

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High intensity lipid lowering
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, statin, blood cholesterol level

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥35 y
  • Symptoms suggestive of stable CAD
  • No pre-CTA known CAD
  • At least one lesion with FFRct <0.81
  • Sinus rhythm
  • LDL cholesterol >2.0 mM
  • Statin use >2 months
  • Life expentancy < 3 years
  • Signed informed consent

Exclusion Criteria:

  • Known CAD
  • Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
  • Significant CAD in the left main or proximal coronary segments
  • Referral to invasive catheterization
  • Statin intolerance
  • BMI >40
  • Allergy to ionidated contrast
  • Pregnancy

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

usual care lipid lowering

Intensive lipid lowering

Arm Description

Usual care: atorvastatin 40 mg

Intensive: rosuvastatin 40 mg + ezetimibe 10 mg

Outcomes

Primary Outcome Measures

Changes in FFRct values
CT derived FFR

Secondary Outcome Measures

Changes in FFRct values
CT derived FFR
Changes in low density plaque volumes
CT determined plaque volumes

Full Information

First Posted
May 6, 2022
Last Updated
November 9, 2022
Sponsor
Aarhus University Hospital
Collaborators
HeartFlow, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05368545
Brief Title
Influence of Lipid Lowering on Impaired Coronary Flow
Official Title
Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
HeartFlow, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow
Detailed Description
Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol >2 mM), and at least one translesional FFRct value <0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
fractional flow reserve, CT derived fractional flow reserve, coronary artery disease, ischemic heart disease, stable chest pain, statin, blood cholesterol level

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care lipid lowering
Arm Type
Active Comparator
Arm Description
Usual care: atorvastatin 40 mg
Arm Title
Intensive lipid lowering
Arm Type
Experimental
Arm Description
Intensive: rosuvastatin 40 mg + ezetimibe 10 mg
Intervention Type
Drug
Intervention Name(s)
High intensity lipid lowering
Other Intervention Name(s)
Usual care lipid lowering
Intervention Description
Two different regimens of drugs with different effects on LDL lowering
Primary Outcome Measure Information:
Title
Changes in FFRct values
Description
CT derived FFR
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Changes in FFRct values
Description
CT derived FFR
Time Frame
9 months
Title
Changes in low density plaque volumes
Description
CT determined plaque volumes
Time Frame
0-9, and 0-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥35 y Symptoms suggestive of stable CAD No pre-CTA known CAD At least one lesion with FFRct <0.81 Sinus rhythm LDL cholesterol >2.0 mM Statin use >2 months Life expentancy < 3 years Signed informed consent Exclusion Criteria: Known CAD Poor CTA image quality inadequiate for FFRct analysis (determined by corelab) Significant CAD in the left main or proximal coronary segments Referral to invasive catheterization Statin intolerance BMI >40 Allergy to ionidated contrast Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjarne Norgaard, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Denamrk
ZIP/Postal Code
8300
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of Lipid Lowering on Impaired Coronary Flow

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