175 Participants Needed

Diagnostic Study for Heart Disease

NS
Overseen ByNathaniel Smilowitz
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: Aspirin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking NSAIDs (like ibuprofen or naproxen) within 3 days and any platelet antagonists other than aspirin and thienopyridines within 7 days before participation.

What data supports the effectiveness of the treatment for Coronary Microvascular Disease?

Research shows that coronary microvascular dysfunction is linked to a higher risk of death and major heart problems, suggesting the importance of effective treatment strategies for this condition.12345

How is the treatment Diagnostic Coronary Angiography with Non-Obstructive CAD different from other treatments for heart disease?

This treatment is unique because it focuses on diagnosing and treating heart disease that originates in the small blood vessels (microcirculation) rather than the larger coronary arteries, which are often the focus of traditional heart disease treatments. It helps identify and manage conditions like microvascular angina, which are often overlooked in patients with normal-looking coronary arteries.678910

What is the purpose of this trial?

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.

Research Team

NS

Nathaniel Smilowitz, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This study is for adult women over 18 with stable ischemic heart disease, who are taking aspirin and referred for coronary angiography. It's not suitable for those with severe heart failure, recent heart attacks, certain blood disorders or bleeding risks, pregnancy, or known allergies to adenosine.

Inclusion Criteria

I am a woman over 18 referred for a heart vessel check.
My heart condition is stable, with symptoms or test results showing reduced blood flow to my heart.
I have taken aspirin before having a heart catheterization.

Exclusion Criteria

I have had heart surgery or a procedure to improve blood flow to my heart.
Pregnancy
Pre-Cath Exclusion criteria:
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Evaluation

Participants undergo diagnostic coronary angiography and invasive measures of coronary microvascular physiology are obtained

1 day
1 visit (in-person)

Sample Collection and Analysis

Blood is collected for analysis of platelet activity, inflammation, and isolation of coronary endothelial cells

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

4 weeks

Treatment Details

Interventions

  • Adenosine
  • Bivalirudin
  • Diagnostic Coronary Angiography with Non-Obstructive CAD
  • Guiding Catheter
  • Heparin
  • Pressure-Temperature Sensor Guidewire
Trial Overview The trial investigates the link between platelet activity, inflammation and coronary microvascular dysfunction using a Pressure-Temperature Sensor Guidewire during angiography. Medications like Bivalirudin, Adenosine and Heparin will be used alongside standard procedures.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Non-Obstructive CADExperimental Treatment5 Interventions
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.

Diagnostic Coronary Angiography with Non-Obstructive CAD is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Statins, ACE inhibitors, Beta blockers, Calcium channel blockers for:
  • Coronary microvascular dysfunction
  • Non-obstructive coronary artery disease
🇺🇸
Approved in United States as Statins, ACE inhibitors, Beta blockers, Calcium channel blockers for:
  • Coronary microvascular dysfunction
  • Non-obstructive coronary artery disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

In a study of 3265 patients with varying degrees of coronary artery disease, those with non-obstructive coronary artery disease (20-50% blockage) had a significantly worse long-term cardiovascular prognosis compared to those with normal coronary arteries, with a hazard ratio of 1.72.
This increased risk was particularly pronounced in non-diabetic patients (hazard ratio 2.12), women (hazard ratio 1.75), and those who had experienced an acute coronary syndrome (hazard ratio 2.07), indicating that non-obstructive coronary artery disease is a serious condition that warrants attention.
Prognostic Implication of Non-Obstructive Coronary Lesions: A New Classification in Different Settings.Rodríguez-Capitán, J., Sánchez-Pérez, A., Ballesteros-Pradas, S., et al.[2021]
Coronary microvascular dysfunction (CMD) is linked to a nearly 4-fold increase in all-cause mortality, with 9.3% of patients with CMD dying compared to only 2.6% of those without it, based on a meta-analysis of 6631 patients.
Patients with CMD also experience a 5-fold increase in major adverse cardiac events, indicating a significant risk associated with CMD that necessitates further research into effective diagnostic and treatment strategies.
Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data.Gdowski, MA., Murthy, VL., Doering, M., et al.[2021]
A significant portion (60-70%) of patients undergoing invasive coronary angiography for angina and myocardial ischemia do not have obstructive coronary disease, with coronary microvascular angina being the cause in nearly 50% of these cases.
Coronary microvascular angina is linked to poor prognosis and quality of life, but advancements in diagnostic methods and treatment options are improving management of this condition.
Coronary Microvascular Angina: A State-of-the-Art Review.Spione, F., Arevalos, V., Gabani, R., et al.[2022]

References

Prognostic Implication of Non-Obstructive Coronary Lesions: A New Classification in Different Settings. [2021]
Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data. [2021]
Coronary Microvascular Angina: A State-of-the-Art Review. [2022]
Myocardial Infarction Without Obstructive Coronary Artery Disease is Not a Benign Condition (ANZACS-QI 10). [2018]
Comparison of Patients With Nonobstructive Coronary Artery Disease With Versus Without Myocardial Infarction (from the VA Clinical Assessment Reporting and Tracking [CART] Program). [2021]
Clinical and electrocardiographic features of patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA). [2021]
Microvascular angina: an update on diagnosis and treatment. [2015]
Prevalence and Prognosis of Nonobstructive Coronary Artery Disease in Patients Undergoing Coronary Angiography or Coronary Computed Tomography Angiography: A Meta-Analysis. [2018]
Sex-based prognostic implications of nonobstructive coronary artery disease: results from the international multicenter CONFIRM study. [2022]
Diagnostic accuracy of 128-row multidetector computed tomography coronary angiography in the diagnosis of significant coronary artery stenosis. [2022]
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