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The study is designed to see if stress echocardiography can be used as a screening exam in peri-, or post-menopausal women with a risk of developing of coronary artery disease and experiencing future cardiac events.
The clinical trial is designed to determine the prognostic value of stress echocardiography as a screening examination in peri-, or post-menopausal female patients with an intermediate likelihood of coronary artery disease (CAD) based on risk factors to identify patients at higher risk of experiencing future cardiac events.Female patients who are able to adequately exercise will undergo a symptom-limited exercise echocardiogram. Patients who are unable to adequately exercise or are predicted to be unable to exercise adequately (because of orthopedic/neurologic limitations, lung disease or debility), will perform dobutamine stress echocardiography. All patients will receive DEFINITY at rest and stress to enhance wall motion assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definity | Experimental | All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflutren Lipid Microsphere Injectable Suspension | Drug | Activated DEFINITY 10ug/kg by bolus injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years 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
| 2 year and 5 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 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
|
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Inclusion Criteria:
Peri or Post menopausal women either:
Must be able to perform an exercise stress test
Peri-or post-menopausal (including surgical menopause) based on history.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Mulvagh, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29672210 | Derived | Abdelmoneim SS, Ball CA, Mantovani F, Hagen ME, Eifert-Rain S, Wilansky S, Castello R, Pellikka PA, Best PJM, Mulvagh SL. Prognostic Utility of Stress Testing and Cardiac Biomarkers in Menopausal Women at Low to Intermediate Risk for Coronary ARTery Disease (SMART Study): 5-Year Outcome. J Womens Health (Larchmt). 2018 May;27(5):542-551. doi: 10.1089/jwh.2017.6506. Epub 2018 Apr 19. | |
| 24932797 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Echocardiography Imaging |
| |||||||||||||
| Efficacy Population |
|
Peri- or post-menopausal female subjects between 40 and 65 years of age with an intermediate likelihood of CAD who are scheduled to undergo stress echocardiography
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Definity | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years 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
| 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 | Posted | Count of Participants | Participants | 2 year and 5 year follow up |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Lantheus Medical Imaging | 978-671-8118 | Sandra.Monte@lantheus.com |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| 2-year follow-up |
| Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 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
| 2 year follow up |
| Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 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
| 2 year follow up |
| 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. | 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
| 2 year and 5 year follow up |
| Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 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 | 2 year follow up |
| The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography | 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. | 60 days |
| Participants With Positive and Negative Angiography Compared With Their ECG Results | 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. | 60 days |
| Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years 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
| 5 year follow up |
| Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 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
| 5 year follow up |
| Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 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
| 5 year follow up |
| Mean Calcium Score of Participants With and Without Major Cardiac Events at 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 | 5 year follow up |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Local Institution | Rochester | Minnesota | 55905 | United States |
| Derived |
| Mantovani F, Abdelmoneim SS, Zysek V, Eifert-Rain S, Mulvagh SL. Effect of stress echocardiography testing on changes in cardiovascular risk behaviors in postmenopausal women: a prospective survey study. J Womens Health (Larchmt). 2014 Jul;23(7):581-7. doi: 10.1089/jwh.2013.4604. Epub 2014 Jun 16. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Definity | 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 |
|
|
|
| Secondary | Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 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
| 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 | Posted | Count of Participants | Participants | 2-year follow-up |
|
|
|
|
| Secondary | Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 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
| Participants with valid BNP measurements at both rest and stress and who participated in 2-year follow up | Posted | Mean | 95% Confidence Interval | pg/mL | 2 year follow up |
|
|
|
| Secondary | Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 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
| Participants with valid ANP measurements at both rest and stress who participated in 2-year follow up | Posted | Mean | 95% Confidence Interval | pg/mL | 2 year follow up |
|
|
|
| Secondary | 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. | 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
| 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. | Posted | Number | 95% Confidence Interval | Percentage | 2 year and 5 year follow up |
|
|
|
| Secondary | Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 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 | Participants with EBCT-based calcium score assessment at baseline who participated in 2-year follow up | Posted | Mean | 95% Confidence Interval | score on a scale (calcium score) | 2 year follow up |
|
|
|
| Secondary | The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography | 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. | Subjects who underwent both rest and stress Definity-enhanced echocardiography and coronary angiography within 60 days | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Participants With Positive and Negative Angiography Compared With Their ECG Results | 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. | Subjects who underwent exercise ECG testing and coronary angiography within 60 days | Posted | Count of Participants | Participants | 60 days |
|
|
|
| Secondary | Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years 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
| 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 | Posted | Number | Percent of participants | 5 year follow up |
|
|
|
| Secondary | Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 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
| Subjects with valid BNP measurements at both rest and stress | Posted | Mean | 95% Confidence Interval | pg/mL | 5 year follow up |
|
|
|
| Secondary | Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up. | 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
| Subjects with valid ANP measurements at both rest and stress and follow up at 5 years | Posted | Mean | 95% Confidence Interval | pg/mL | 5 year follow up |
|
|
|
| Secondary | Mean Calcium Score of Participants With and Without Major Cardiac Events at 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 | Participants with EBCT-based calcium score assessment at baseline who participated in 5-year follow up | Posted | Mean | 95% Confidence Interval | score on a scale (calcium score) | 5 year follow up |
|
|
|
| 0 |
| 400 |
| 6 |
| 400 |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Urticaria NOS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Not provided
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
|
|
| Mean %change of brachial artery diameter from rest to stress in subjects w/o MACE at 5 year followup |
|
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| Mean %change of brachial artery diameter from rest to stress in subjects w/MACE at 5 year followup |
|
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| Subjects w/positive coronary angiography and Definity-enhanced stress echo wall motion abnormality |
|
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| Subjects w/positive coronary angiography and positive ECG |
|
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|
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