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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00587678
Enrollment
85
Registered
2008-01-07
Start date
2006-01-31
Completion date
2009-10-31
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

PAD

Brief summary

The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.

Interventions

DRUGSimvastatin

40mg each night

DRUGEzetimibe

10mg daily

DRUGSimvastatin/Ezetimibe

40mg/10mg each night

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4\<ABI\<0.9) 96 Normal healthy subjects ages 30-85

Exclusion criteria

Age\<30, \>85 GFR less than 45mL/min based on a serum creatinine drawn within 90 days of the MRI: Pregnancy Contraindications to a magnetic resonance examination * Intracranial clips * Implantable pacemaker and defibrillator * Cochlear or intraocular implants * Claustrophobia * Any metallic implant not listed as magnetic resonance compatible in Shellock F.G ---Pocket Guide to Magnetic Resonance Procedures and Metallic Objects, Update 2000. Lippincott, Williams and Wilkins

Design outcomes

Primary

MeasureTime frameDescription
Plaque Volume2 yearsSFA plaque volume
Perfusion Index2 yearsPerfusion 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.
Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.2 yearsPhosphocreatine 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.

Secondary

MeasureTime frameDescription
Triglycerides2 years—
Magnetic Resonance Angiographic Index2 yearsMRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.
Low Density Lipoprotein Cholesterol2 years—
6-minute Walk Distance2 years—
V02 - Maximal Oxygen Consumption2 years—
Log Treadmill Exercise Time2 years—
Total Cholesterol2 years—
High Density Lipoprotein Cholesterol2 years—

Countries

United States

Participant flow

Participants by arm

ArmCount
Simvastatin 40mg
Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
22
Simvastatin 40mg/Ezetimibe 10 mg
Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
22
Ezetimibe 10mg
Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
41
Total85

Baseline characteristics

CharacteristicTotalEzetimibe 10mgSimvastatin 40mg/Ezetimibe 10 mgSimvastatin 40mg
6-minute walk distance1024 feet
STANDARD_DEVIATION 397
1007 feet
STANDARD_DEVIATION 435
976 feet
STANDARD_DEVIATION 324
1103 feet
STANDARD_DEVIATION 407
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
38 Participants21 Participants11 Participants6 Participants
Age, Categorical
Between 18 and 65 years
47 Participants20 Participants11 Participants16 Participants
Age, Continuous63 years
STANDARD_DEVIATION 11
66 years
STANDARD_DEVIATION 11
64 years
STANDARD_DEVIATION 9
59 years
STANDARD_DEVIATION 12
High density lipoprotein cholesterol43 mg/dl
STANDARD_DEVIATION 13
42 mg/dl
STANDARD_DEVIATION 2
48 mg/dl
STANDARD_DEVIATION 4
45 mg/dl
STANDARD_DEVIATION 4
Log of Treadmill Exercise Time5.95 log of time in seconds
STANDARD_DEVIATION 0.76
5.94 log of time in seconds
STANDARD_DEVIATION 0.78
5.82 log of time in seconds
STANDARD_DEVIATION 0.67
6.08 log of time in seconds
STANDARD_DEVIATION 0.84
Low density lipoprotein cholesterol111 mg/dl
STANDARD_DEVIATION 35
100 mg/dl
STANDARD_DEVIATION 4
118 mg/dl
STANDARD_DEVIATION 9
118 mg/dl
STANDARD_DEVIATION 10
Lumen volume6.0 cm3
STANDARD_DEVIATION 3.8
5.7 cm3
STANDARD_DEVIATION 0.5
5.9 cm3
STANDARD_DEVIATION 1.1
6.7 cm3
STANDARD_DEVIATION 1.2
Magnetic resonance angiographic index0.81 units on a scale (0-4). 0 = normal.
STANDARD_DEVIATION 0.64
0.65 units on a scale (0-4). 0 = normal.
STANDARD_DEVIATION 0.62
1.10 units on a scale (0-4). 0 = normal.
STANDARD_DEVIATION 0.72
0.73 units on a scale (0-4). 0 = normal.
STANDARD_DEVIATION 0.5
Perfusion index0.48 Units on a scale (0 = worst, 1 = best).
STANDARD_DEVIATION 0.16
0.51 Units on a scale (0 = worst, 1 = best).
STANDARD_DEVIATION 0.16
0.42 Units on a scale (0 = worst, 1 = best).
STANDARD_DEVIATION 0.13
0.48 Units on a scale (0 = worst, 1 = best).
STANDARD_DEVIATION 0.18
Phosphocreatine recovery time constant92 seconds
STANDARD_DEVIATION 64
83 seconds
STANDARD_DEVIATION 62
104 seconds
STANDARD_DEVIATION 56
94 seconds
STANDARD_DEVIATION 77
Plaque volume10.6 cm^3
STANDARD_DEVIATION 5.4
10.0 cm^3
STANDARD_DEVIATION 0.8
11.5 cm^3
STANDARD_DEVIATION 1.4
11.0 cm^3
STANDARD_DEVIATION 1.5
Region of Enrollment
United States
85 participants41 participants22 participants22 participants
Sex: Female, Male
Female
37 Participants21 Participants10 Participants6 Participants
Sex: Female, Male
Male
48 Participants20 Participants12 Participants16 Participants
Total cholesterol182 mg/dl
STANDARD_DEVIATION 45
170 mg/dl
STANDARD_DEVIATION 6
189 mg/dl
STANDARD_DEVIATION 10
194 mg/dl
STANDARD_DEVIATION 11
Total vessel volume16.6 cm^3
STANDARD_DEVIATION 8.7
15.7 cm^3
STANDARD_DEVIATION 1.2
17.5 cm^3
STANDARD_DEVIATION 2.4
17.7 cm^3
STANDARD_DEVIATION 2.5
Triglycerides159 mg/dl
STANDARD_DEVIATION 104
157 mg/dl
STANDARD_DEVIATION 20
130 mg/dl
STANDARD_DEVIATION 21
227 mg/dl
STANDARD_DEVIATION 47
V02 max - maximal oxygen consumption12.8 ml/kg/min
STANDARD_DEVIATION 4
12.1 ml/kg/min
STANDARD_DEVIATION 3.8
12.4 ml/kg/min
STANDARD_DEVIATION 3.2
14.6 ml/kg/min
STANDARD_DEVIATION 4.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 220 / 220 / 41
serious
Total, serious adverse events
0 / 240 / 220 / 41

Outcome results

Primary

Perfusion Index

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.

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgPerfusion Index0.34 Units on a scale (0 = worst, 1 = best)Standard Deviation 0.19
Simvastatin 40mg/Ezetimibe 10 mgPerfusion Index0.37 Units on a scale (0 = worst, 1 = best)Standard Deviation 0.13
Ezetimibe 10mgPerfusion Index0.54 Units on a scale (0 = worst, 1 = best)Standard Deviation 0.2
p-value: 0.71Linear repeated measures model
Primary

Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.

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.

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgPhosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.84 secondsStandard Deviation 68
Simvastatin 40mg/Ezetimibe 10 mgPhosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.73 secondsStandard Deviation 35
Ezetimibe 10mgPhosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau.74 secondsStandard Deviation 58
p-value: 0.67Linear repeated measures model
Primary

Plaque Volume

SFA plaque volume

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgPlaque Volume10.5 cm^3Standard Deviation 1.4
Simvastatin 40mg/Ezetimibe 10 mgPlaque Volume10.5 cm^3Standard Deviation 1.3
Ezetimibe 10mgPlaque Volume10.8 cm^3Standard Deviation 0.9
p-value: 0.32Linear repeated measures model
p-value: <0.01Linear repeated measures model
Secondary

6-minute Walk Distance

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mg6-minute Walk Distance1078 ft.Standard Deviation 485
Simvastatin 40mg/Ezetimibe 10 mg6-minute Walk Distance1038 ft.Standard Deviation 248
Ezetimibe 10mg6-minute Walk Distance1099 ft.Standard Deviation 394
p-value: 0.77Linear repeated measures model
Secondary

High Density Lipoprotein Cholesterol

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgHigh Density Lipoprotein Cholesterol44 mg/dlStandard Deviation 4
Simvastatin 40mg/Ezetimibe 10 mgHigh Density Lipoprotein Cholesterol46 mg/dlStandard Deviation 3
Ezetimibe 10mgHigh Density Lipoprotein Cholesterol43 mg/dlStandard Deviation 3
p-value: 0.78Linear repeated measures model
Secondary

Log Treadmill Exercise Time

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgLog Treadmill Exercise Time5.92 log time in secondsStandard Deviation 1.08
Simvastatin 40mg/Ezetimibe 10 mgLog Treadmill Exercise Time5.79 log time in secondsStandard Deviation 0.67
Ezetimibe 10mgLog Treadmill Exercise Time5.78 log time in secondsStandard Deviation 0.63
p-value: =0.67linear repeated measures model
Secondary

Low Density Lipoprotein Cholesterol

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgLow Density Lipoprotein Cholesterol83 mg/dlStandard Deviation 11
Simvastatin 40mg/Ezetimibe 10 mgLow Density Lipoprotein Cholesterol68 mg/dlStandard Deviation 10
Ezetimibe 10mgLow Density Lipoprotein Cholesterol77 mg/dlStandard Deviation 5
p-value: 0.31Linear repeated measures model
p-value: <0.05Linear repeated measures model
Secondary

Magnetic Resonance Angiographic Index

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

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgMagnetic Resonance Angiographic Index0.71 units on scale (0 = normal, 4 = worst)Standard Deviation 0.46
Simvastatin 40mg/Ezetimibe 10 mgMagnetic Resonance Angiographic Index1.32 units on scale (0 = normal, 4 = worst)Standard Deviation 0.86
Ezetimibe 10mgMagnetic Resonance Angiographic Index0.63 units on scale (0 = normal, 4 = worst)Standard Deviation 0.64
p-value: <0.05Linear repeated measures model
Secondary

Total Cholesterol

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgTotal Cholesterol152 mg/dlStandard Deviation 12
Simvastatin 40mg/Ezetimibe 10 mgTotal Cholesterol136 mg/dlStandard Deviation 12
Ezetimibe 10mgTotal Cholesterol144 mg/dlStandard Deviation 6
p-value: 0.37Linear repeated measures model
p-value: <0.05Linear repeated measures model
Secondary

Triglycerides

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgTriglycerides171 mg/dlStandard Deviation 30
Simvastatin 40mg/Ezetimibe 10 mgTriglycerides119 mg/dlStandard Deviation 20
Ezetimibe 10mgTriglycerides152 mg/dlStandard Deviation 15
p-value: 0.68Linear repeated measures model
Secondary

V02 - Maximal Oxygen Consumption

Time frame: 2 years

ArmMeasureValue (MEAN)Dispersion
Simvastatin 40mgV02 - Maximal Oxygen Consumption14.8 ml/min/kgStandard Deviation 4.6
Simvastatin 40mg/Ezetimibe 10 mgV02 - Maximal Oxygen Consumption12.1 ml/min/kgStandard Deviation 2.9
Ezetimibe 10mgV02 - Maximal Oxygen Consumption12.3 ml/min/kgStandard Deviation 4.6
p-value: 0.85Linear repeated measures model

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026