Diagnostic Study for Heart Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NYU Langone Health
Must be taking: Aspirin
Must not be taking: NSAIDs, Platelet antagonists
Disqualifiers: Anemia, Thrombocytosis, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345How 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.
678910Eligibility 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:
+16 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
New York University School of MedicineNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
References
Prognostic Implication of Non-Obstructive Coronary Lesions: A New Classification in Different Settings. [2021]The clinical significance of non-obstructive coronary artery disease is the subject of debate. Our objective was to evaluate the long-term cardiovascular prognosis associated with non-obstructive coronary artery disease in patients undergoing coronary angiography, and to conduct a stratification by sex, diabetes, and clinical indication. We designed a multi-centre retrospective longitudinal observational study of 3265 patients that were classified into three groups: normal coronary arteries (lesion 70%, 1196 patients). During a mean follow-up of 43 months, we evaluated a combined cardiovascular event: acute myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death. Multivariable-adjusted Cox proportional hazard models showed a worse prognosis in patients with non-obstructive coronary artery disease, in comparison with patients of normal coronary arteries group, in the total population (hazard ratio 1.72, 95% confidence interval 1.23-2.39; p for trend
Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data. [2021]Background The impact of coronary microvascular dysfunction (CMD), as diagnosed by reduced coronary flow reserve, on the outcomes of patients with symptoms of myocardial ischemia and nonobstructive coronary artery disease is poorly understood. We performed a systematic review and meta-analysis of observational studies to determine the association of CMD with outcomes. Methods and Results We searched online databases for studies where coronary flow reserve was measured invasively or noninvasively, clinical events were recorded after determination of coronary flow reserve, and the frequency of those events was reported for patients with and without CMD. The primary outcome was all-cause mortality. The secondary outcome was major adverse cardiac events, including cardiac or cardiovascular death, nonfatal myocardial infarction, cardiac hospitalization, or coronary revascularization. Estimates of effect were calculated from crude event rates with a random-effects model. There were 122 deaths in the 4661 patients without CMD (2.6%) and 183 deaths in the 1970 patients with CMD (9.3%). The odds ratio for mortality in patients with CMD compared with those without CMD was 3.93 (95% CI, 2.91-5.30; P<0.001). There were 167 major adverse cardiac events in the 3742 patients without CMD (4.5%) and 245 events in the 1447 patients with CMD (16.9%). The odds ratio for major adverse cardiac events in patients with CMD compared with those without CMD was 5.16 (95% CI, 2.81-9.47; P<0.001). Conclusions CMD is associated with a nearly 4-fold increase in mortality and a 5-fold increase in major adverse cardiac events. Future studies are needed to identify effective strategies to diagnose and treat CMD.
Coronary Microvascular Angina: A State-of-the-Art Review. [2022]Up to 60-70% of patients, undergoing invasive coronary angiography due to angina and demonstrable myocardial ischemia with provocative tests, do not have any obstructive coronary disease. Coronary microvascular angina due to a dysfunction of the coronary microcirculation is the underlying cause in almost 50% of these patients, associated with a bad prognosis and poor quality of life. In recent years, progress has been made in the diagnosis and management of this condition. The aim of this review is to provide an insight into current knowledge of this condition, from current diagnostic methods to the latest treatments.
Myocardial Infarction Without Obstructive Coronary Artery Disease is Not a Benign Condition (ANZACS-QI 10). [2018]Non-obstructive coronary artery disease (CAD) on coronary angiography after myocardial infarction (MI) is associated with a lower risk of adverse outcomes, but the prognosis may not be benign. Our aim was to assess outcomes in MI with and without obstructive CAD, and in an age and sex matched comparison cohort without known cardiovascular disease.
Comparison of Patients With Nonobstructive Coronary Artery Disease With Versus Without Myocardial Infarction (from the VA Clinical Assessment Reporting and Tracking [CART] Program). [2021]Comparisons of the outcomes of patients with myocardial infarction with nonobstructive coronary artery disease (MINOCA) and patients with nonobstructive coronary artery disease (CAD) without myocardial infarction (MI) are limited. Here we compare the outcomes of patients with MINOCA and patients with nonobstructive CAD without MI and assess the influence of medical therapy on outcomes in these patients. Veterans who underwent coronary angiography between 2008 to 2017 with nonobstructive CAD were divided into those with or without pre-procedural troponin elevation. Patients with prior revascularization, heart failure, or who presented with cardiogenic shock, STEMI, or unstable angina were excluded. After propensity matching, outcomes were compared between groups. The primary outcome was major adverse cardiovascular events (MACE: mortality, myocardial infarction, and revascularization) within one year: 3,924 patients with nonobstructive CAD and a troponin obtained prior to angiography were identified (n=1,986 with elevated troponin) and restricted to 1,904 patients after propensity-matching. There was a significantly higher risk of MACE among troponin-positive patients compared with those with a negative troponin (HR 2.37; 95% CI, 1.67 to 3.34). Statin (HR 0.32; 95% CI, 0.22 to 0.49) and ACE inhibitor (HR 0.49; 95% CI, 0.32 to 0.75) therapy after angiography was associated with decreased MACE, while P2Y12 inhibitor, calcium-channel and beta-blocker therapy were not associated with outcomes. In conclusion, Veterans with MINOCA are at increased risk for MACE compared with those with nonobstructive CAD and negative troponin at the time of angiography. Specific medications were associated with a reduction in MACE, suggesting an opportunity to explore novel approaches for secondary prevention in this population.
Clinical and electrocardiographic features of patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA). [2021]Myocardial infarction with non-obstructive coronary artery disease (MINOCA) is often an underdiagnosed and undertreated condition. This study aimed to evaluate clinical and ECG characteristics of MINOCA in a large cohort of patients admitted for acute coronary syndrome.
Microvascular angina: an update on diagnosis and treatment. [2015]Many patients with chest pain who are relieved to learn that they have no obstructive stenoses at diagnostic angiography are misclassified as having noncardiac chest pain. Only recently have we developed the conceptual framework and diagnostic tools to understand that ischemic heart disease is not exclusively caused by obstructive coronary artery disease, but often has its origin in the microcirculation. This article will focus on the diagnosis and treatment of microvascular angina as a cause of myocardial ischemia in patients with abnormal but 'normal appearing' coronary arteries.
Prevalence and Prognosis of Nonobstructive Coronary Artery Disease in Patients Undergoing Coronary Angiography or Coronary Computed Tomography Angiography: A Meta-Analysis. [2018]To evaluate the prevalence, clinical characteristics, and risk of cardiac events in patients with nonobstructive coronary artery disease (CAD).
Sex-based prognostic implications of nonobstructive coronary artery disease: results from the international multicenter CONFIRM study. [2022]To determine the clinical outcomes of women and men with nonobstructive coronary artery disease ( CAD coronary artery disease ) with coronary computed tomographic (CT) angiography data in patients who were similar in terms of CAD coronary artery disease risk factors, angina typicality, and CAD coronary artery disease extent and distribution.
Diagnostic accuracy of 128-row multidetector computed tomography coronary angiography in the diagnosis of significant coronary artery stenosis. [2022]To evaluate the diagnostic accuracy of 128-multi detector row computed tomography coronary angiography (MDCTCA) with that of invasive conventional coronary angiography (CCA) in the diagnosis of coronary artery disease (CAD).