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
  Purpose

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.


Condition
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • development of cardiovascular disease [ Time Frame: annually for 4 years after baseline visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, plasma


Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Perimenopausal women
Women at the beginning stages of menopause

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Perimenopausal women

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921011

Locations
United States, Ohio
The Ohio State Univeristy Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Subha V Raman, MD Ohio State University
  More Information

No publications provided

Responsible Party: Subha Raman, Professor of Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT00921011     History of Changes
Other Study ID Numbers: 2008H0308, 1 RO1 HL095563-01
Study First Received: June 15, 2009
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
hypertension
diabetes
smoking
hyperlipidemia
atherosclerosis risk

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014