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Completed

NCT Number: NCT00162370

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peri or Post menopausal women either:
  • without symptoms but with risk factors for heart disease OR
  • experiencing atypical chest pain, OR
  • experiencing exertional dyspnea AND 2 or more risk factors for CAD
  • Must be able to perform an exercise stress test

Peri-or post-menopausal (including surgical menopause) based on history.

  • Post-menopausal is defined as females age 40-65 who self-report the absence of menstrual periods for at least 12 months.
  • Peri-menopausal is defined as females age 40-65 who self-report the absence or irregularity of menstrual periods for 6-12 months.
  • Surgical menopause is defined as females who have had a bilateral salpingo-oophorectomy with or without hysterectomy.

Exclusion criteria

  • Previous confirmed heart disease

Treatment and study plan

Perflutren Lipid Microsphere Injectable Suspension

Drug

Activated DEFINITY 10ug/kg by bolus injection

Other names: DEFINITY

Primary outcomes

  1. Number of Participants With Abnormal Contrast Stress Echocardiography and With Future Major Adverse Cardiac Events (MACE) at 2 and 5 Years Follow-Up

    Time frame: 2 year and 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

Secondary outcomes

  1. Number of Participants With Abnormal ECG and With Major Adverse Cardiac Events (MACE) at 2 Year Follow-Up

    Time frame: 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

  2. Change in Brain Natriuretic Peptide (BNP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.

    Time frame: 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

  3. Change in Atrial Natriuretic Peptide (ANP) in Subjects With and Without Major Adverse Cardiac Events at 2-year Follow-up.

    Time frame: 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

  4. 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.

    Time frame: 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

    • 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

  5. Mean Baseline Calcium Score of Participants With and Without Major Cardiac Events at 2-year Follow up.

    Time frame: 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

  6. The Presence of Wall Motion Abnormalities on Definity Stress Echocardiography Assessed for Participants With Both Normal and Abnormal Angiography

    Time frame: 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.

  7. Participants With Positive and Negative Angiography Compared With Their ECG Results

    Time frame: 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.

  8. Number of Participants With Abnormal ECG and With Future Major Adverse Cardiac Events (MACE) at 5 Years Follow-Up

    Time frame: 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

  9. Change in Brain Natriuretic Peptide (BNP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.

    Time frame: 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

    • 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

  10. Change in Atrial Natriuretic Peptide (ANP) in Participants With and Without Major Adverse Cardiac Events at 5-year Follow-up.

    Time frame: 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

    • 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

  11. Mean Calcium Score of Participants With and Without Major Cardiac Events at 5-year Follow up.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study title

SMART: Stress Echocardiography in Menopausal Women at Risk for Coronary Artery Disease Trial

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2005
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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