Benefits of Exercise Training in Women With Ischemic Syndrome

A Pilot Study to Test the Benefits of Exercise Training in Women With Ischemic Syndrome

Angina in the absence of obstructive coronary artery disease is highly prevalent in women, and leads to increased risk for major cardiovascular events, including myocardial infarction, stroke, and heart failure. Annual mortality rates are ten-fold higher than mortality from breast cancer, and the lifetime cost of health care for women with non-obstructive chest pain is close to $1 million. Coronary microvascular dysfunction is a major etiological feature of this disease, and may contribute to disease progression. Despite our general understanding, effective treatment remains elusive. This pilot study will test whether regular exercise training can improve/reverse coronary microvascular dysfunction in women with angina but no obstructive coronary artery disease.

Study Overview

• Status: Withdrawn
• Conditions: Microvascular Coronary Dysfunction
• Intervention / Treatment: Behavioral: Exercise training

Detailed Description

We will study 10 women with signs and symptoms of ischemia but no evidence of obstructive coronary artery disease.

Procedures:

Aerobic fitness: Incremental exercise test to volitional exhaustion on a exercise bike to assess the maximal rate of oxygen consumption.

Cardiac magnetic resonance imaging: To assess cardiac morphology and function. Cardiac perfusion imaging: Using MRI, we will assess the rate of uptake of a contrast media (gadolinium) at rest and in response to a vasodilating substance (adenosine) to evaluate myocardial perfusion reserve.

Protocol:

Participants will undergo aerobic fitness testing, cardiac MRI and perfusion imaging at baseline and following 8-weeks of regular exercise training.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women with persistent chest pain but no obstructive disease (defined as 50% luminal diameter stenosis in >1 epicardial coronary arteries)
2. Fully understanding and willing to undergo study procedures
3. Understanding and willing to sign consent form.

Exclusion Criteria:

1. Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support;
2. Planned percutaneous coronary intervention or coronary artery bypass graft or established obstructive CAD with ischemia eligible for revascularization,
3. Acute myocardial infarction;
4. Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
5. Prior non-cardiac illness with an estimated life expectancy <4 years;
6. Unable to give informed consent;
7. Allergy or contra-indication to cardiac magnetic resonance imaging, including renal failure, claustrophobia, and asthma, uncontrolled moderate hypertension (sitting blood pressure >160/95 mmHg with measurements recorded on at least 2 occasions), conditions likely to influence outcomes: Severe lung, creatinine >1.8 or CrCl ≤ 50ml/min) or hepatic disease;
8. Contraindications to adenosine or regadensoson (Lexiscan)
9. Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months;
10. Adherence or retention issues;
11. Unwilling to complete follow-up evaluation;
12. Aortic stenosis (valve area <1.5cm);
13. Left ventricular systolic dysfunction (ejection fraction <35%);
14. Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir);
15. Women who are pregnant.
16. Allergy to animal dander.
17. Unable to perform exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Training; Subjects will exercise for 8 weeks	Behavioral: Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the maximal rate of myocardial oxygen consumption	Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in myocardial perfusion reserve index	change from baseline at 8 weeks
Change in left ventricular diastolic function	change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PRO37771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes