Trial Outcomes & Findings for Comprehensive Magnetic Resonance of Peripheral Arterial Disease (NCT NCT00587678)

NCT ID: NCT00587678

Last Updated: 2017-08-21

Results Overview

SFA plaque volume

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-08-21

Participant Flow

Participant milestones

Measure	Simvastatin 40mg Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Overall Study STARTED	22	22	41
Overall Study COMPLETED	16	18	33
Overall Study NOT COMPLETED	6	4	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Baseline characteristics by cohort

Measure	Simvastatin 40mg n=22 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=22 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=41 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants	47 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants	38 Participants n=4 Participants
Age, Continuous	59 years STANDARD_DEVIATION 12 • n=5 Participants	64 years STANDARD_DEVIATION 9 • n=7 Participants	66 years STANDARD_DEVIATION 11 • n=5 Participants	63 years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	48 Participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	41 participants n=5 Participants	85 participants n=4 Participants
Total cholesterol	194 mg/dl STANDARD_DEVIATION 11 • n=5 Participants	189 mg/dl STANDARD_DEVIATION 10 • n=7 Participants	170 mg/dl STANDARD_DEVIATION 6 • n=5 Participants	182 mg/dl STANDARD_DEVIATION 45 • n=4 Participants
Low density lipoprotein cholesterol	118 mg/dl STANDARD_DEVIATION 10 • n=5 Participants	118 mg/dl STANDARD_DEVIATION 9 • n=7 Participants	100 mg/dl STANDARD_DEVIATION 4 • n=5 Participants	111 mg/dl STANDARD_DEVIATION 35 • n=4 Participants
High density lipoprotein cholesterol	45 mg/dl STANDARD_DEVIATION 4 • n=5 Participants	48 mg/dl STANDARD_DEVIATION 4 • n=7 Participants	42 mg/dl STANDARD_DEVIATION 2 • n=5 Participants	43 mg/dl STANDARD_DEVIATION 13 • n=4 Participants
Triglycerides	227 mg/dl STANDARD_DEVIATION 47 • n=5 Participants	130 mg/dl STANDARD_DEVIATION 21 • n=7 Participants	157 mg/dl STANDARD_DEVIATION 20 • n=5 Participants	159 mg/dl STANDARD_DEVIATION 104 • n=4 Participants
Plaque volume	11.0 cm^3 STANDARD_DEVIATION 1.5 • n=5 Participants	11.5 cm^3 STANDARD_DEVIATION 1.4 • n=7 Participants	10.0 cm^3 STANDARD_DEVIATION 0.8 • n=5 Participants	10.6 cm^3 STANDARD_DEVIATION 5.4 • n=4 Participants
Total vessel volume	17.7 cm^3 STANDARD_DEVIATION 2.5 • n=5 Participants	17.5 cm^3 STANDARD_DEVIATION 2.4 • n=7 Participants	15.7 cm^3 STANDARD_DEVIATION 1.2 • n=5 Participants	16.6 cm^3 STANDARD_DEVIATION 8.7 • n=4 Participants
Lumen volume	6.7 cm3 STANDARD_DEVIATION 1.2 • n=5 Participants	5.9 cm3 STANDARD_DEVIATION 1.1 • n=7 Participants	5.7 cm3 STANDARD_DEVIATION 0.5 • n=5 Participants	6.0 cm3 STANDARD_DEVIATION 3.8 • n=4 Participants
Perfusion index	0.48 Units on a scale (0 = worst, 1 = best). STANDARD_DEVIATION 0.18 • n=5 Participants	0.42 Units on a scale (0 = worst, 1 = best). STANDARD_DEVIATION 0.13 • n=7 Participants	0.51 Units on a scale (0 = worst, 1 = best). STANDARD_DEVIATION 0.16 • n=5 Participants	0.48 Units on a scale (0 = worst, 1 = best). STANDARD_DEVIATION 0.16 • n=4 Participants
Phosphocreatine recovery time constant	94 seconds STANDARD_DEVIATION 77 • n=5 Participants	104 seconds STANDARD_DEVIATION 56 • n=7 Participants	83 seconds STANDARD_DEVIATION 62 • n=5 Participants	92 seconds STANDARD_DEVIATION 64 • n=4 Participants
Magnetic resonance angiographic index	0.73 units on a scale (0-4). 0 = normal. STANDARD_DEVIATION 0.50 • n=5 Participants	1.10 units on a scale (0-4). 0 = normal. STANDARD_DEVIATION 0.72 • n=7 Participants	0.65 units on a scale (0-4). 0 = normal. STANDARD_DEVIATION 0.62 • n=5 Participants	0.81 units on a scale (0-4). 0 = normal. STANDARD_DEVIATION 0.64 • n=4 Participants
Log of Treadmill Exercise Time	6.08 log of time in seconds STANDARD_DEVIATION 0.84 • n=5 Participants	5.82 log of time in seconds STANDARD_DEVIATION 0.67 • n=7 Participants	5.94 log of time in seconds STANDARD_DEVIATION 0.78 • n=5 Participants	5.95 log of time in seconds STANDARD_DEVIATION 0.76 • n=4 Participants
6-minute walk distance	1103 feet STANDARD_DEVIATION 407 • n=5 Participants	976 feet STANDARD_DEVIATION 324 • n=7 Participants	1007 feet STANDARD_DEVIATION 435 • n=5 Participants	1024 feet STANDARD_DEVIATION 397 • n=4 Participants
V02 max - maximal oxygen consumption	14.6 ml/kg/min STANDARD_DEVIATION 4.6 • n=5 Participants	12.4 ml/kg/min STANDARD_DEVIATION 3.2 • n=7 Participants	12.1 ml/kg/min STANDARD_DEVIATION 3.8 • n=5 Participants	12.8 ml/kg/min STANDARD_DEVIATION 4.0 • n=4 Participants

PRIMARY outcome

Timeframe: 2 years

SFA plaque volume

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Plaque Volume	10.5 cm^3 Standard Deviation 1.4	10.5 cm^3 Standard Deviation 1.3	10.8 cm^3 Standard Deviation 0.9

PRIMARY outcome

Timeframe: 2 years

Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Perfusion Index	0.34 Units on a scale (0 = worst, 1 = best) Standard Deviation 0.19	0.37 Units on a scale (0 = worst, 1 = best) Standard Deviation 0.13	0.54 Units on a scale (0 = worst, 1 = best) Standard Deviation 0.20

PRIMARY outcome

Timeframe: 2 years

Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.	84 seconds Standard Deviation 68	73 seconds Standard Deviation 35	74 seconds Standard Deviation 58

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Low Density Lipoprotein Cholesterol	83 mg/dl Standard Deviation 11	68 mg/dl Standard Deviation 10	77 mg/dl Standard Deviation 5

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Total Cholesterol	152 mg/dl Standard Deviation 12	136 mg/dl Standard Deviation 12	144 mg/dl Standard Deviation 6

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
High Density Lipoprotein Cholesterol	44 mg/dl Standard Deviation 4	46 mg/dl Standard Deviation 3	43 mg/dl Standard Deviation 3

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Triglycerides	171 mg/dl Standard Deviation 30	119 mg/dl Standard Deviation 20	152 mg/dl Standard Deviation 15

SECONDARY outcome

Timeframe: 2 years

MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Magnetic Resonance Angiographic Index	0.71 units on scale (0 = normal, 4 = worst) Standard Deviation 0.46	1.32 units on scale (0 = normal, 4 = worst) Standard Deviation 0.86	0.63 units on scale (0 = normal, 4 = worst) Standard Deviation 0.64

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
Log Treadmill Exercise Time	5.92 log time in seconds Standard Deviation 1.08	5.79 log time in seconds Standard Deviation 0.67	5.78 log time in seconds Standard Deviation 0.63

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
6-minute Walk Distance	1078 ft. Standard Deviation 485	1038 ft. Standard Deviation 248	1099 ft. Standard Deviation 394

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Simvastatin 40mg n=16 Participants Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years	Simvastatin 40mg/Ezetimibe 10 mg n=18 Participants Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years	Ezetimibe 10mg n=33 Participants Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
V02 - Maximal Oxygen Consumption	14.8 ml/min/kg Standard Deviation 4.6	12.1 ml/min/kg Standard Deviation 2.9	12.3 ml/min/kg Standard Deviation 4.6

Adverse Events

Simvastatin 40mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Simvastatin 40mg/Ezetimibe 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ezetimibe 10mg

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

Dr Christopher Kramer

University of Virginia

Phone: 434-243-0736

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place