NCT02374086

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

February 18, 2015

Last Update Submit

April 22, 2019

Conditions

Microvascular Coronary Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in the maximal rate of myocardial oxygen consumption

    Change from baseline at 8 weeks

Secondary Outcomes (2)

  • Change in myocardial perfusion reserve index

    change from baseline at 8 weeks

  • Change in left ventricular diastolic function

    change from baseline at 8 weeks

Study Arms (1)

Exercise Training

EXPERIMENTAL

Subjects will exercise for 8 weeks

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL
Exercise Training

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Acute coronary syndrome (defined by WHO), cardiogenic shock or requiring inotropic or intra-aortic balloon support;
  • Planned percutaneous coronary intervention or coronary artery bypass graft or established obstructive CAD with ischemia eligible for revascularization,
  • Acute myocardial infarction;
  • Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
  • Prior non-cardiac illness with an estimated life expectancy \<4 years;
  • Unable to give informed consent;
  • 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;
  • Contraindications to adenosine or regadensoson (Lexiscan)
  • Surgically uncorrected significant congenital or valvular heart disease and other disease likely to be fatal or require frequent hospitalization within the next six months;
  • Adherence or retention issues;
  • Unwilling to complete follow-up evaluation;
  • Aortic stenosis (valve area \<1.5cm);
  • Left ventricular systolic dysfunction (ejection fraction \<35%);
  • Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir);
  • Women who are pregnant.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • C. Noel Bairey Merz, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 27, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)