Trial Outcomes & Findings for Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression (NCT NCT01212900)
NCT ID: NCT01212900
Last Updated: 2018-11-30
Results Overview
Wall volume of internal carotid arteries was measured using magnetic resonance imaging. Participants will undergo 2D and 3D carotid MRI using a 3 Tesla scanner and surface carotid coils. Participants with mild or no atherosclerosis, defined as the lowest tertile of wall volume, will have statin therapy adjusted to a target range of 100-130 mg/dL. Participants in the middle tertile will receive statin therapy adjusted to achieve a target LDL 70-100 mg/dL. Participants with the most severe atherosclerosis will receive statin therapy to an LDL target between 40 and 70 mg/dL. Participants in the Standard arm will have lipid sub-fraction targets determined according to estimated 10 year cardiovascular risk, as per standard NCEP guidelines.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
230 participants
Primary outcome timeframe
24 months
Results posted on
2018-11-30
Participant Flow
Participant milestones
| Measure |
Imaging
Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
|
Standard
Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
114
|
|
Overall Study
COMPLETED
|
104
|
107
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
Baseline characteristics by cohort
| Measure |
Imaging
n=116 Participants
Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
|
Standard
n=114 Participants
Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
|
Total
n=230 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
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The analyses included only those subjects who were assigned standardized statin doses based on imaging of carotids at baseline based on NCEP ATP IIIR guidelines.
Wall volume of internal carotid arteries was measured using magnetic resonance imaging. Participants will undergo 2D and 3D carotid MRI using a 3 Tesla scanner and surface carotid coils. Participants with mild or no atherosclerosis, defined as the lowest tertile of wall volume, will have statin therapy adjusted to a target range of 100-130 mg/dL. Participants in the middle tertile will receive statin therapy adjusted to achieve a target LDL 70-100 mg/dL. Participants with the most severe atherosclerosis will receive statin therapy to an LDL target between 40 and 70 mg/dL. Participants in the Standard arm will have lipid sub-fraction targets determined according to estimated 10 year cardiovascular risk, as per standard NCEP guidelines.
Outcome measures
| Measure |
Imaging
n=91 Participants
Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
|
Standard
n=89 Participants
Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
|
|---|---|---|
|
Change in Mean of Wall Volume of Internal Carotid Arteries
|
-3.52 Other - mm^3 ( cubic millimeter )
Interval -7.552305 to 0.506032
|
-5.91 Other - mm^3 ( cubic millimeter )
Interval -10.9683601 to -0.8536061
|
Adverse Events
Imaging
Serious events: 18 serious events
Other events: 58 other events
Deaths: 0 deaths
Standard
Serious events: 18 serious events
Other events: 51 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Imaging
n=116 participants at risk
Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
|
Standard
n=114 participants at risk
Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
General disorders
Death
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Pneumonia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Investigations
Blood creatine abnormal
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Investigations
Haemoglobin abnormal
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Investigations
Hepatic enzyme abnormal
|
0.86%
1/116 • 24 months
|
2.6%
3/114 • 24 months
|
|
Investigations
Hospitalisation
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
adenocarcinoma
|
0.86%
1/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biopsy skin
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gingival cancer
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Nervous system disorders
Spinal cord herniation
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Psychiatric disorders
Amnesia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottitis
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Aortic surgery
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Arthroscopic surgery
|
2.6%
3/116 • 24 months
|
2.6%
3/114 • 24 months
|
|
Surgical and medical procedures
Breast conserving surgery
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Cardiac ablation
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Elective procedure
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Thyroidectomy
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Uterine prolapse repair
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Vascular disorders
Carotid artery aneurysm
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
Other adverse events
| Measure |
Imaging
n=116 participants at risk
Lipid targets assigned according to the severity of atherosclerotic plaque measured as wall volume in the common and internal carotid arteries by MRI
|
Standard
n=114 participants at risk
Standardized statin therapy based on NCEP ATP IIIR guidelines, including clinical risk factors and blood lipid levels.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Cardiac disorders
Dyspnoea
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Cardiac disorders
Palpitations
|
1.7%
2/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Cardiac disorders
Presyncope
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Endocrine disorders
Goitre
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Eye disorders
Dry eye
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Eye disorders
Retinal haemorrhage
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.86%
1/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Gastrointestinal disorders
Glossodynia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
General disorders
Chest pain
|
1.7%
2/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
General disorders
fatigue
|
2.6%
3/116 • 24 months
|
2.6%
3/114 • 24 months
|
|
General disorders
Nodule
|
0.00%
0/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
General disorders
Oedema
|
1.7%
2/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Hepatobiliary disorders
Haemangioma of liver
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Genitourinary tract infection
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Infection
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Pneumonia
|
0.86%
1/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Infections and infestations
Sinusitis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Injury, poisoning and procedural complications
Spinal cord herniation
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Investigations
Blood creatine abnormal
|
0.00%
0/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Investigations
Blood pressure increased
|
0.86%
1/116 • 24 months
|
2.6%
3/114 • 24 months
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Investigations
Pregnancy test false positive
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.4%
4/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.7%
2/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle contractions involuntary
|
2.6%
3/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle rupture
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.86%
1/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
2.6%
3/116 • 24 months
|
4.4%
5/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.7%
2/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
2/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff repair
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.7%
2/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Upper limb fracture
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Nervous system disorders
Facial paralysis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/116 • 24 months
|
2.6%
3/114 • 24 months
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Nervous system disorders
Tremor
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Psychiatric disorders
Amnesia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Psychiatric disorders
Anxiety
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Psychiatric disorders
Insomnia
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Renal and urinary disorders
Flank pain
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Adductor vocal cord weakness
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Adenoviral upper respiratory infection
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic sinusitis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.86%
1/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/116 • 24 months
|
1.8%
2/114 • 24 months
|
|
Surgical and medical procedures
Acupuncture
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Antidepressant therapy
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Breast operation
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Cyst drainage
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Hernia repair
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Meniscus operation
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Radioactive iodine therapy
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Tendon operation
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Surgical and medical procedures
Vocal cord polypectomy
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
|
Vascular disorders
Hypertension
|
0.86%
1/116 • 24 months
|
0.00%
0/114 • 24 months
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/116 • 24 months
|
0.88%
1/114 • 24 months
|
Additional Information
Mehta, Nehal
National Heart Lung and Blood Institute
Phone: +1 301 827 0483
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place