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RecruitingNCT02301663Updated Sep 1, 2023

Development of a Novel Stress Testing Protocol to Define the Relationship Between Coronary Microvascular Dysfunction and Diastology in Women With Angina But No Evidence of Obstructive Coronary Artery Disease

An interventional study of Handgrip and Altitude simulation in Microvascular Coronary Dysfunction, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
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Study summary

Microvascular coronary dysfunction (MCD) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. There are an estimated 2-3 million women in the US with MCD and about 100,000 new cases annually. Recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. This pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. The investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). Subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.

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Conditions studied

  • Microvascular Coronary Dysfunction
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 30 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

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.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Fully understanding and willing to undergo study procedures
  2. Male or Female greater than or equal to 18 years of age
  3. Understanding and willing to sign consent form.

Exclusion criteria

Exclusion Criteria:

  1. History of cardiovascular, pulmonary, or neurological disease
  2. Hypertension (sitting blood pressure >140/90 mmHg, with measurements recorded on at least 2 occasions)
  3. Diabetes
  4. Unable to give informed consent;
  5. Contra-indication to CMRI testing, including claustrophobia and metallic implants
  6. Adherence or retention issues;
  7. Women who are pregnant.
  8. Allergy to animal dander.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Women w/microvascular disease

    10 women with microvascular disease

    Other: Handgrip · Other: Altitude simulation · Other: Leg exercise

  • Experimental
    Normal controls

    10 age-matched women with no evidence of microvascular disease

    Other: Handgrip · Other: Altitude simulation · Other: Leg exercise

  • Experimental
    calibration

    10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.

    Other: Handgrip · Other: Altitude simulation · Other: Leg exercise

Interventions

  • OtherHandgrip

    Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand

  • OtherAltitude simulation

    Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.

  • OtherLeg exercise

    Subjects will perform leg exercise to increase metabolic demand.

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What researchers measure

Primary outcomes

  1. Diastolic function by MRI

    Time frame: 24 hours

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, 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
NCT02301663
Lead sponsor
Cedars-Sinai Medical Center
Responsible party
Noel Bairey Merz (Director, Cedars-Sinai Medical Center) — Principal investigator
First posted
Nov 26, 2014
Start date
Nov 2014
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 1, 2023

Study contacts

Barbra Streisand Women's Heart Center
Contact
310-423-9666
Michael Nelson, PhD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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