Trial Outcomes & Findings for Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging (NCT NCT02114697)

Last Updated: 2018-09-11

Results Overview

Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm\^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

Baseline, 18 months, 36 months

Results posted on

2018-09-11

Participant Flow

A total of 11 individuals gave informed consent to participate in the study, however, one withdrew from the study and one was lost to follow up before being assigned to a study arm. These individuals are not considered as enrolled as no clinical data were collected. Nine participants were assigned to a study arm and began the intervention.

Participant milestones

Participant milestones
Measure	Lifestyle Modification Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.	Statin Therapy Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
Overall Study STARTED	5	4
Overall Study Completed Month 18 Visit	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lifestyle Modification Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.	Statin Therapy Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
Overall Study Study terminated	5	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Modification n=5 Participants Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.	Statin Therapy n=4 Participants Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=9 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=9 Participants
Age, Continuous	60.60 years STANDARD_DEVIATION 3.64 • n=5 Participants	62.25 years STANDARD_DEVIATION 1.70 • n=4 Participants	61.33 years STANDARD_DEVIATION 2.06 • n=9 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline, 18 months, 36 months

Population: This analysis includes all participants who completed the MRI at each time point. Most participants did not return for the follow up MRI measurements.

Outcome measures

Outcome measures
Measure	Lifestyle Modification n=5 Participants Participants receiving information about lifestyle modifications including a recommended exercise regimen, a healthy diet and decreasing alcohol intake.	Statin Therapy n=4 Participants Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
Plaque Volume of Carotid Arteries Baseline	125.18 Cubic millimeter (mm^3) Standard Deviation 8.09	108.88 Cubic millimeter (mm^3) Standard Deviation 5.27
Plaque Volume of Carotid Arteries Month 18	—	114.70 Cubic millimeter (mm^3) Standard Deviation 0.0

Adverse Events

Lifestyle Modification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Statin Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Oshinski PhD

Emory University

Phone: 404-727-5894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place