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

NCT00162370 | Completed Phase 4 Results

• 1 other identifier: DMP 115-407
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Artery Disease; Heart Disease

Outcome Measures

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

  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

  2 year and 5 year follow up

Secondary Outcomes (11)

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

  2-year follow-up

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

  2 year follow up

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

  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.

  2 year and 5 year follow up

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

  2 year follow up

Study Arms (1)

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.

Drug: Perflutren Lipid Microsphere Injectable Suspension

Interventions

Perflutren Lipid Microsphere Injectable Suspension DRUG

Activated DEFINITY 10ug/kg by bolus injection

Also known as: DEFINITY

Definity

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous confirmed heart disease

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (3)

Local Institution

Scottsdale, Arizona, 85259, United States

Location

Local Institution

Jacksonville, Florida, 32224, United States

Location

Local Institution

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 29672210 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.

  PMID: 24932797 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Interventions

perflutren

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Lantheus Medical Imaging

Sandra.Monte@lantheus.com

978-671-8118

Study Officials

• Sharon Mulvagh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: April 1, 2004
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 15, 2021
• Results First Posted: December 8, 2016

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)