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Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Subha Raman, Ohio State University
ClinicalTrials.gov Identifier:
NCT00921011
First received: June 15, 2009
Last updated: May 5, 2014
Last verified: May 2014

June 15, 2009
May 5, 2014
May 2009
April 2015   (final data collection date for primary outcome measure)
vessel wall changes over time that precede plaque buildup [ Time Frame: baseline, 1-year follow-up and 2-year follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921011 on ClinicalTrials.gov Archive Site
development of cardiovascular disease [ Time Frame: annually for 4 years after baseline visit ] [ Designated as safety issue: No ]
development of cardiovascular disease [ Time Frame: 1-year and 2-year follow-up after baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis
Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

The study hypothesis (or theory) is that monthly loss of iron before menopause may reduce women's risk of hardening of the arteries, or atherosclerosis.

This study uses noninvasive, noncontrast magnetic resonance imaging (MRI) of arteries in women entering menopause. This will help to determine if there is a correlation between iron accumulation and hardening of the arteries. In addition, blood levels of hormones will be measured to help show differences due to hormone levels vs. iron accumulation.

Atherosclerosis, or hardening of the arteries, is the underlying disease responsible for the vast majority of cardiovascular morbidity and mortality and afflicted over 30 million Americans in 2005. While the prevalence of atherosclerosis is similar in women and men, women enjoy a ~5-10 year lag in onset of cardiovascular events compared to men. After menopause, a state defined by marked reduction in ovarian hormone production, the incidence of events such as heart attack and stroke caused by atherosclerotic plaque rises up to threefold regardless of age range. This has prompted numerous investigations of hormone therapy (HT) to lower cardiovascular risk to premenopausal levels. Therapeutic trials, however, have not realized a cardiovascular benefit; in fact, initiating HT in large randomized trials did not decrease and possibly increased cardiovascular risk. Studies of coronary heart disease prevention have shown mixed results using estrogen alone vs. estrogen plus progestin, while studies of stroke prevention have consistently shown increased risk with HT. Clearly, different therapeutic interventions warrant consideration. This proposal seeks to investigate a novel perspective using longitudinal clinical studies in women at risk of atherosclerosis. The studies involve a new noncontrast, noninvasive MRI method with blood tests that measure cholesterol, hormone levels, and inflammation.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum, plasma

Probability Sample

Perimenopausal women

Atherosclerosis
Not Provided
Perimenopausal women
Women at the beginning stages of menopause
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women at least 40 yrs of age
  • between 1 and 6 menstrual cycles in the past 12 months
  • 2 or more of the following risk factors: high blood pressure, diabetes, high cholesterol, smoking
  • no known heart or vascular disease

Exclusion Criteria:

  • any known cardiovascular disease such as coronary disease, peripheral vascular disease, heart failure
  • contraindication to MRI scan (e.g. aneurysm clip, iron-containing metal)

NOTE that orthopedic hardware is usually MRI-compatible. We will go over detailed screening before enrollment.

Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00921011
2008H0308, 1 RO1 HL095563-01
Yes
Subha Raman, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Subha V Raman, MD Ohio State University
Ohio State University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP