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WithdrawnNCT02374086Updated Apr 23, 2019

Benefits of Exercise Training in Women With Ischemic Syndrome

An interventional study of Exercise training in Microvascular Coronary Dysfunction, sponsored by Cedars-Sinai Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Enrollment slower than usual.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Microvascular Coronary Dysfunction
03

In context

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Exercise Training

    Subjects will exercise for 8 weeks

    Behavioral: Exercise training

Interventions

  • BehavioralExercise training
06

What researchers measure

Primary outcomes

  1. Change in the maximal rate of myocardial oxygen consumption

    Time frame: Change from baseline at 8 weeks

Secondary outcomes

  1. Change in myocardial perfusion reserve index

    Time frame: change from baseline at 8 weeks

  2. Change in left ventricular diastolic function

    Time frame: change from baseline at 8 weeks

07

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02374086
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Noel Bairey Merz (Director, Cedars-Sinai Medical Center) — Principal investigator
First posted
Feb 27, 2015
Start date
Jan 2016
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Apr 23, 2019

Study contacts

C. Noel Bairey Merz, MD
principal investigator · Cedars-Sinai Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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