Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

Iron and Atherosclerosis: Longitudinal Study in Perimenopausal Women With Risk Factors for Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921011
• Other study ID #: 2008H0308
• Secondary ID: R01HL095563
• Status: Completed
• First received: June 15, 2009
• Last updated: April 3, 2018
• Start date: May 2009
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
United States	The Ohio State Univeristy Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vessel wall changes over time that precede plaque buildup		baseline, 1-year follow-up and 2-year follow-up
Secondary	development of cardiovascular disease		annually for 4 years after baseline visit