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A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03537586
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
84
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Among patients with stable ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Ischemia based on symptoms or stress testing may be due to coronary microvascular dysfunction in up to 40% of these patients. However, the mechanisms and optimal treatment of coronary microvascular dysfunction are unknown. Aberrant platelet activity and inflammation have been hypothesized as mechanisms of microvascular dysfunction. Investigators plan to evaluate association between platelet activity, inflammation, and coronary microvascular dysfunction in stable women referred for coronary angiography, and to identify non-invasive correlates of coronary microvascular dysfunction in these patients.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic Coronary Angiography with Non-Obstructive CAD
 N/A

Detailed Description

The objectives of this study are to

  1. Investigate platelet activity and inflammation in patients with and without coronary microvascular disease who are referred for coronary angiography for the evaluation of stable ischemic heart disease and are found to have non-obstructuve epicardial CAD

  2. To identify correlates of coronary microvascular dysfunction in non coronary microvascular beds that can be characterized in vivo.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Actual Study Start Date :
Jun 29, 2018
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non-Obstructive CAD

After diagnostic coronary angiography, invasive measures of coronary microvascular physiology will be obtained. Blood will be collected for platelet activity, inflammation and isolation of coronary endothelial cells. Evaluation of the sublingual microvasculature with a side stream dark field imaging video microscope will be performed.

Diagnostic Test: Diagnostic Coronary Angiography with Non-Obstructive CAD
Platelet activity in patients with and without CMVD (measured as a dichotomous variable) will be compared using the independent samples T-Test (for normally distributed data) of the Mean-Whitney U test.

Outcome Measures

Primary Outcome Measures

  1. Platelet Activity measured by the Index of Microcirculatory Resistance (IMR) [12 Months]

  2. Measure of Inflammation measured by the Index of Microcirculatory Resistance (IMR) [12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 125 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult women age ≥18 years referred for coronary angiography

  • Stable ischemic heart disease, defined by ischemic symptoms and/or myocardial ischemia by stress testing

  • Administration of aspirin therapy prior to cardiac catheterization

Exclusion Criteria:
Pre-Cath Exclusion criteria:

  • Active bleeding and/or bleeding diathesis

  • Anemia (hemoglobin <9 mg/dl)

  • Known thrombocytosis (platelet count >500,000)

  • Know thrombocytopenia (platelet count <100,000)

  • NSAIDs (e.g., ibuprofen, naproxen) within 3 days

  • Platelet antagonists other than aspirin and thienopyridines, within 7 days

  • Prior percutaneous coronary intervention or coronary artery bypass grafting

  • Acute myocardial infarction within 3 months

  • Severe valvular heart disease

  • Cardiogenic shock or mechanical circulatory support

  • New York Heart Association (NYHA) Functional Class III or IV heart failure

  • Ejection Fraction <40%

  • Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy

  • Pregnancy

  • Contraindication to intravenous infusion of adenosine during coronary angiography, due to known hypersensitivity to adenosine, known or suspected bronchoconstrictive or bronchospastic lung disease (severe asthma), second- or third-degree AV block (except in patients with a functioning artificial pacemaker), or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia,

Angiographic Exclusion criteria:

  • Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)

  • Unfavorable coronary artery anatomy for guidewire positioning (as determined by the angiographer or PI)

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Nathaniel Smilowitz, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03537586
Other Study ID Numbers:
  • 18-00116
First Posted:
May 25, 2018
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Microvascular Angina
Ischemia

Study Results

No Results Posted as of May 2, 2022