Trial Outcomes & Findings for A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease (NCT NCT00162370)

NCT ID: NCT00162370

Last Updated: 2021-03-15

Results Overview

Peri- or post-menopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received a Definity contrast-enhanced stress echocardiography study at baseline using either treadmill exercise or dobutamine stresss. Images were evaluated for wall motion abnormalities. The results were compared to patient history on 2-year and 5-year follow up to identify the potential of stress echocardiography for predicting those at higher risk of experiencing future cardiac events. Major adverse cardiac events (MACE) are defined as * Cardiac death * Myocardial infarction * Cardiac revascularization (PCI or CABG) * Hospitalization for chest pain or to rule out myocardial infarction * Development of typical angina * Development of heart failure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 400 participants
• Primary outcome timeframe: 2 year and 5 year follow up
• Results posted on: 2021-03-15

Participant Flow

Participant milestones

Measure	Definity Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Completed Echocardiography Imaging STARTED	366
Completed Echocardiography Imaging COMPLETED	366
Completed Echocardiography Imaging NOT COMPLETED	0
Efficacy Population STARTED	366
Efficacy Population COMPLETED	315
Efficacy Population NOT COMPLETED	51

Reasons for withdrawal

Measure

Definity Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection

Efficacy Population Lost to Follow-up

51

Baseline Characteristics

A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease

Baseline characteristics by cohort

Measure	Definity n=400 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	394 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	54.4 Years n=5 Participants
Sex: Female, Male Female	400 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	386 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	400 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year and 5 year follow up

Population: Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and participated in 2 year or 5 year follow up

Peri- or post-menopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received a Definity contrast-enhanced stress echocardiography study at baseline using either treadmill exercise or dobutamine stresss. Images were evaluated for wall motion abnormalities. The results were compared to patient history on 2-year and 5-year follow up to identify the potential of stress echocardiography for predicting those at higher risk of experiencing future cardiac events.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=363 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up Abnormal contrast stress echo and any major cardiac event at 2 year follow up	2 Participants
Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up Normal contrast stress echo and any major cardiac event at 2 year follow up	1 Participants
Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up Abnormal contrast stress echo and any major cardiac event at 5 year follow up	1 Participants
Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up Normal contrast stress echo and any major cardiac event at 5 year follow up	5 Participants

SECONDARY outcome

Timeframe: 2-year follow-up

Population: Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and participated in 2 year follow up

Prognostic value of stress ECG testing for identifying female patients at increased risk of major adverse cardiac events (MACE) at 2-year follow-up

Peri- or post-meopausal female subjects with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting ECG at baseline. ECG was evaluated as normal or abnormal. The results were compared to patient history on 2-year follow up to identify the potential for ECG to predict those at higher risk of experiencing future cardiac events.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=18 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up Number of subjects with abnormal stress ECG at baseline who had MACE at 2 years	3 Participants
Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up Number of subjects with abnormal stress ECG at baseline who did not have MACE at 2 years	15 Participants

SECONDARY outcome

Timeframe: 2 year follow up

Population: Participants with valid BNP measurements at both rest and stress and who participated in 2-year follow up

The value of exercise-induced changes in blood concentration of cardiac peptide, brain natriuretic peptide (BNP in pg/mL in blood), was assessed in identifying patients with cardiac events at 2-year follow-up. The change in mean BNP blood concentration from rest to stress at baseline is summarized using number of subjects with and without MACE at 2-year follow-up

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=236 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. Change of BNP from rest to stress in subjects without major cardiac events at 2 year followup	5.2 pg/mL Interval 0.61 to 9.79
Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. Change of BNP from rest to stress in subjects with major cardiac events at 2 year followup	10.7 pg/mL Interval -32.5 to 53.9

SECONDARY outcome

Timeframe: 2 year follow up

Population: Participants with valid ANP measurements at both rest and stress who participated in 2-year follow up

The value of exercise-induced changes in blood concentration of cardiac peptide, atrial natriuretic peptide (ANP in pg/mL in blood), was assessed in identifying patients with cardiac events at 2-year follow-up. The change in mean ANP blood concentration from rest to stress at baseline is summarized using number of subjects with and without major adverse cardiac events (MACE) at 2-year follow-up.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=179 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. Change of ANP from rest to stress in subjects without major cardiac events at 2-year follow-up	5.9 pg/mL Interval -98.81 to 110.61
Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up. Change of ANP from rest to stress in subjects with major cardiac events at 2-year follow-up	101 pg/mL Interval -716.32 to 918.32

SECONDARY outcome

Timeframe: 2 year and 5 year follow up

Population: Subjects with valid brachial artery diameter asurements at both rest and stress. Note that among the subjects in the trial who had MACE either at 2 year or 5 years, none had been assessed for brachial artery reactivity.

A subset of the study population of peri- or post-meopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) was assessed for brachial artery reactivity at baseline. Brachial diameter was assessed using ultrasound and a pressure cuff both before and after administration of sublingual nitroglycerin. The results were compared to patient history on 2-year and 5-year follow up to identify the potential for brachial artery reactivity to predict those at higher risk of experiencing future cardiac events.The brachial artery reactivity was summarized using number of subjects with and without MACE on follow-up.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=11 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Change in Brachial Artery Reactivity Was Assessed in in a Subset of Participants With and Without Major Adverse Cardiac Events at 2-year and 5-year Follow-up. Mean %change of brachial artery diameter from rest to stress in subjects w/o MACE at 2 year followup	7.8 Percentage Interval 4.33 to 11.27
Change in Brachial Artery Reactivity Was Assessed in in a Subset of Participants With and Without Major Adverse Cardiac Events at 2-year and 5-year Follow-up. Mean %change of brachial artery diameter from rest to stress in subjects w/o MACE at 5 year followup	7.3 Percentage Interval 4.32 to 10.28

SECONDARY outcome

Timeframe: 2 year follow up

Population: Participants with EBCT-based calcium score assessment at baseline who participated in 2-year follow up

Coronary artery calcium scoring assesses calcification of the coronary arteries using electron-beam computed tomography (EBCT). It is a sum of lesion scores of area and density above a threshold density. There is no intrinsic upper limit to the calcium score but values above 1000 may not be measurable.

A subset of peri- or post-meopausal females with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting EBCT at baseline. Images were evaluated for calcium score and results compared to patient history on 2-year follow up, Mean calcium score with confidence interval was summarized for subjects with and without major cardiac events (MACE) at 2-year follow up.

Calcium score for general population:

Score Description Relative Risk 0 No evidence of CAD 0 1-112 Average Risk of CAD 1.9 100-400 Moderate risk of CAD 4.3 400-999 High risk of CAD 7.2 1000 Very high risk of CAD 10.8

Outcome measures

Measure

Definity n=82 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection

Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up. Mean calcium score of subjects without major cardiac events at 2 year follow-up

45 score on a scale (calcium score) Interval 16.51 to 73.49

SECONDARY outcome

Timeframe: 60 days

Population: Subjects who underwent both rest and stress Definity-enhanced echocardiography and coronary angiography within 60 days

In the sub-set of efficacy-evaluable participants who underwent clinically indicated coronary angiography, the accuracy of exercise echocardiography vs. angiography was determined for the detection of CAD. Positive angiography was defined as any stenosis greater than or equal to 50% in any vessel. Wall motion index change indicating abnormal motion was defined as greater than or equal to 13% in 2 or more segments. Angiography was required to have taken place within 60 days following stress echocardiography.

Outcome measures

Measure	Definity n=24 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography Subjects w/negative coronary angiography w/o Definity-enhanced stress echo wall motion abnormality	7 Participants
The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography Subjects w/negative coronary angiography with Definity-enhanced stress echo wall motion abnormality	12 Participants
The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography Subjects w/positive coronary angiography w/o Definity-enhanced stress echo wall motion abnormality	1 Participants
The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography Subjects w/positive coronary angiography and Definity-enhanced stress echo wall motion abnormality	4 Participants

SECONDARY outcome

Timeframe: 60 days

Population: Subjects who underwent exercise ECG testing and coronary angiography within 60 days

In the sub-set of efficacy-evaluable participants who underwent clinically indicated coronary angiography, the accuracy of exercise ECG vs. angiography was determined for the detection of CAD. Positive angiography was defined as any stenosis greater than or equal to 50% in any vessel.

Outcome measures

Measure	Definity n=24 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Participants With Positive and Negative Angiography Compared With Their ECG Results Subjects w/positive coronary angiography and positive ECG	2 Participants
Participants With Positive and Negative Angiography Compared With Their ECG Results Subjects negative coronary angiography and negative ECG	15 Participants
Participants With Positive and Negative Angiography Compared With Their ECG Results Subjects negative coronary angiography and positive ECG	4 Participants
Participants With Positive and Negative Angiography Compared With Their ECG Results Subjects w/positive coronary angiography and negative ECG	3 Participants

SECONDARY outcome

Timeframe: 5 year follow up

Population: Subject has received a physical exam, completed patient history profile, undergone the protocol-specific unenhanced and DEFINITY enhanced rest and stress echocardiography, had the necessary blood work for the study and 2 and/or 5 year follow up

Prognostic value of stress ECG testing for identifying female patients at increased risk of major adverse cardiac events (MACE) at 5-year follow-up

Peri- or post-meopausal female participants with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting ECG at baseline. ECG was evaluated as normal or abnormal. The results were compared to patient history on 5-year follow up to identify the potential for ECG to predict those at higher risk of experiencing future major adverse cardiac events (MACE) at 5-year follow up.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=265 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up Percent of subjects with abnormal stress ECG at baseline who had MACE at 5 years	16.7 Percent of participants
Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up Percent of subjects with abnormal stress ECG at baseline who did not have MACE at 5 years	5.0 Percent of participants

SECONDARY outcome

Timeframe: 5 year follow up

Population: Subjects with valid BNP measurements at both rest and stress

The value of exercise-induced changes in blood concentration of the cardiac peptide, brain natriuretic peptide (BNP in pg/mL in blood), was assessed in identifying patients with cardiac events at 5-year follow-up. The change in mean BNP blood concentration at baseline from rest to stress is summarized using number of participants with and without MACE at 5-year follow up.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=234 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. Change of BNP from rest to stress in subjects without major cardiac events at 5 year followup	4.9 pg/mL Interval 0.28 to 9.52
Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. Change of BNP from rest to stress in subjects with major cardiac events at 5 year followup	4.1 pg/mL Interval -11.89 to 20.09

SECONDARY outcome

Timeframe: 5 year follow up

Population: Subjects with valid ANP measurements at both rest and stress and follow up at 5 years

The baseline value of exercise-induced changes in blood concentration of the cardiac peptide, atrial natriuretic peptide (ANP in pg/mL in blood), was assessed in identifying patients with cardiac events at 5-year follow-up. The change in mean ANP blood concentration from rest to stress at baseline was summarized using number of subjects with and without major adverse cardiac events (MACE) at 5-year follow up.

Major adverse cardiac events (MACE) are defined as

• Cardiac death
• Myocardial infarction
• Cardiac revascularization (PCI or CABG)
• Hospitalization for chest pain or to rule out myocardial infarction
• Development of typical angina
• Development of heart failure

Outcome measures

Measure	Definity n=178 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. Change of ANP from rest to stress in subjects without major cardiac events at 5-year follow-up	-37.4 pg/mL Interval -165.64 to 90.84
Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. Change of ANP from rest to stress in subjects with major cardiac events at 5-year follow-up	70.5 pg/mL Interval -471.2 to 612.2

SECONDARY outcome

Timeframe: 5 year follow up

Population: Participants with EBCT-based calcium score assessment at baseline who participated in 5-year follow up

Coronary artery calcium scoring assesses calcification of the coronary arteries using electron-beam computed tomography (EBCT). It is a sum of lesion scores of area and density above a threshold density. There is no intrinsic upper limit to the calcium score but values above 1000 may not be measurable.

A subset of peri- or post-meopausal females with an intermediate pre-test likelihood of coronary artery disease (CAD) received resting EBCT at baseline. Images were evaluated for calcium score and results compared to patient history on 5-year follow up, Mean calcium score with confidence interval was summarized for subjects with and without major cardiac events (MACE) at 5-year follow up

Calcium score for general population:

Score Description Relative Risk 0 No evidence of CAD 0 1-112 Average Risk of CAD 1.9 100-400 Moderate risk of CAD 4.3 400-999 High risk of CAD 7.2 1000 Very high risk of CAD 10.8

Outcome measures

Measure	Definity n=91 Participants Open-label, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri- and post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up. Mean calcium score of subjects without major cardiac events at 5 year follow-up	40.2 score on a scale (calcium score) Interval 14.52 to 65.88
Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up. Mean calcium score of subjects with major cardiac events at 5 year follow-up	100 score on a scale (calcium score) As there was only one participant in this category, a confidence interval could not be calculated

Adverse Events

Definity

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Definity n=400 participants at risk Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events. Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection
Musculoskeletal and connective tissue disorders Back Disorder	0.25% 1/400 • Number of events 1
Musculoskeletal and connective tissue disorders Back Pain	0.75% 3/400 • Number of events 3
Musculoskeletal and connective tissue disorders Muscle Spasm	0.25% 1/400 • Number of events 1
Nervous system disorders Headache	0.25% 1/400 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.25% 1/400 • Number of events 1
Skin and subcutaneous tissue disorders Urticaria NOS	0.25% 1/400 • Number of events 1

Additional Information

Director, Clinical Operations

Lantheus Medical Imaging

Phone: 978-671-8118

Email: Sandra.Monte@lantheus.com

Results disclosure agreements

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

Restriction type: LTE60