NCT00823563

Evaluation of Patients With Non-obstructive Coronary Arteries

Evaluation of Patients With Angina in the Absence of Obstructive Coronary Artery Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with angina and non-obstructive CAD are common within clinical practice, but remain a challenge with regard to diagnosis and treatment. When these patients undergo a comprehensive evaluation at the time of invasive coronary angiography, occult coronary abnormalities are frequently found. We hope to learn the overall prevalence and presentation of these occult coronary abnormalities and its long term outcome in this patient population.

Detailed description

This is a prospective registry of patients with chest pain, chest discomfort, breathlessness who do not have a blockage in their heart artery. This condition is known as angina/ischemia and non-obstructive coronary arteries (ANOCA/INOCA). The purpose of this registry is to help us understand the prevalence, causes of these conditions, identify effective diagnostic strategy, and long term outcome in this patient population. Patients will undergo comprehensive invasive evaluation including coronary angiography, intravascular imaging, and physiologic measurements as a standard of care. Details regarding the participant's angiogram, endothelial function testing, microvascular testing, intravascular ultrasound, and myocardial bridge testing, if performed, will be entered into a research database. Participants may be contacted by email or phone periodically for follow-up information, such as surveys, an update on medical history, and/or a check on their medical status or symptoms. We anticipate gathering these data at 6 months, 1 year, 3 years, 5 years, and 10 years, and every 5 years thereafter following their enrollment. The overall objective of this registry study is to identify specific endotypes of ANOCA by invasive evaluation and study long term outcome. Specific goals include: 1. Describe the prevalence of the following ANOCA endotypes: endothelial dysfunction, microvascular dysfunction, vasospastic angina, myocardial bridging (MB), and other disorders of coronary physiology, and non-cardiac chest pain; 2. Characterize the natural history and outcomes of patients with ANOCA and determine variables associated with major adverse cardiovascular events

Conditions

• Chest Pain
• Ischemia

Interventions

Type	Name	Description
PROCEDURE	30 cc blood draw
PROCEDURE	Intravascular ultrasound (IVUS)
PROCEDURE	Coronary pressure/flow wire testing
PROCEDURE	Coronary pressure/flow testing: Acetycholine challenge
PROCEDURE	Procedure: Coronary pressure/flow testing: Nitroglycerin challenge
PROCEDURE	Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge

Timeline

• Start date: 2007-06-01
• Primary completion: 2047-06-01
• Completion: 2047-06-01
• First posted: 2009-01-15
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States