Registry Study for Microvascular Angina

(DISCOVER INOCA Trial)

Recruiting at 9 trial locations

Overseen By Cody Pietras

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, Myocardial infarction, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand a heart condition called INOCA, where people experience heart disease symptoms without major artery blockages. Researchers use special tools to examine blood flow and the inside of arteries to identify different types of this condition and track long-term patient outcomes. It suits individuals advised they might have heart disease and are scheduled for coronary angiography but lack major blockages. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance future heart disease diagnosis and treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these methods are safe for evaluating INOCA?

Previous studies have found the Abbott Coroventis Coroflow Cardiovascular System safe for measuring blood flow and assessing the condition of heart blood vessels. However, it should not monitor vital signs, as it lacks alarm features for patients.

Coronary angiography, a procedure to view blood vessels, carries a low risk of complications. Serious issues occur in less than 2% of cases, and the risk of death is below 0.08%, indicating most patients tolerate it well.

Intravascular imaging, which allows doctors to see inside blood vessels, has proven safe for guiding heart procedures. It ensures these procedures are performed effectively and safely, without adding extra risk compared to other methods.

Overall, these tools and procedures have been well-studied and are considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DISCOVER INOCA Prospective Multi-center Registry because it explores innovative diagnostic tools for ischemia with no obstructive coronary arteries (INOCA), a condition that lacks effective standard treatments. Unlike traditional diagnostic methods like stress tests or basic angiography, this trial employs advanced technologies such as the Abbott Coroventis Coroflow Cardiovascular System and intravascular imaging. These tools provide a more detailed view of the coronary flow and vessel structure, potentially leading to more accurate diagnoses and personalized treatment plans. By understanding the microvascular and endothelial function more thoroughly, researchers hope to unlock new pathways for managing INOCA, ultimately improving patient outcomes.

What evidence suggests that the Abbott Coroventis Coroflow Cardiovascular System is effective for identifying phenotypes of INOCA?

Research has shown that the Abbott Coroventis Coroflow Cardiovascular System effectively measures key heart functions. Measurements like fractional flow reserve help doctors assess blood flow in the heart. Studies have found that tools like the Coroflow System can improve treatment for patients with heart problems.

Coronary angiography identifies heart issues by providing clear images of blood vessels. Research indicates that this technique can lead to better long-term outcomes, such as fewer heart-related deaths.

Intravascular imaging, another method under study, provides a detailed view inside blood vessels. Studies show it can enhance treatment success and reduce risks, such as heart attacks, by aiding doctors in making informed decisions. Overall, these tools hold promise for improving heart health assessments and patient outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Alexandra Lansky, MD

Principal Investigator

Yale University Medical School

Samit Shah, MD, PhD

Principal Investigator

Yale University Medical School

Are You a Good Fit for This Trial?

Inclusion Criteria

Suspected ischemic heart disease and is referred to undergo clinically indicated invasive coronary angiography

No obstructive coronary artery disease (CAD) as defined by operator visual assessment with (1) angiographically normal coronary arteries OR (2) non-obstructive CAD with angiographic stenosis < 50%, or greater than or equal to 50 but < 70% with FFR greater than or equal to 0.81 or RFR greater than or equal to 0.90

Willing to comply with specified follow-up evaluations. The participant or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo coronary angiography, intravascular imaging, and physiologic measurements using the Coroventis Coroflow Cardiovascular System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, with assessments of anxiety, angina, and quality of life

5 years

At baseline, 30 days, 6 months, 1 year, and annually up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Abbott Coroventis Coroflow Cardiovascular System
• Coronary Angiography
• Intravascular Imaging

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/percutaneous-coronary-intervention/coroventis-coroflow/about.html

Information About Coroventis CoroFlow | Abbott Coroventis CoroFlow Cardiovascular System is an advanced platform to measure physiological indices: fractional flow reserve and resting full-cycle ratio.

2. coroventis.com coroventis.com/wp-content/uploads/2017/09/Coroventis-CoroFlow-CE-2017.pdf

Coroventis CoroFlow Cardiovascular System The Coroventis CoroFlow system is an advanced platform for assessing coronary physiology, providing many hemodynamic parameters for near complete cardiac ...

3. arheart.com arheart.com/wp-content/uploads/2021/08/CoroFlow_Admin_Pres_Final_MAT-2102544.pdf

Coronary Microvascular Dysfunction 1-year outcomes of angina management guided by invasive coronary function testing (CorMicA). JACC Intv. 2020; 13:33-45. 4. “Coroventis CoroFlow Cardiovascular ...

4. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.102179

Multicenter Prospective Assessment of Coronary ... FlowLab was a multicenter, prospective study of patients with possible CMD in whom the treating physician used the CoroFlow bolus ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11308200/

A Systematic Approach to the Evaluation of the Coronary ... Coronary flow reserve and cardiovascular outcomes: a systematic review and meta-analysis. Eur Heart J. 2022;43(16):1582–1593. doi: 10.1093 ...

6. cardiovascular.abbott cardiovascular.abbott/us/en/hcp/products/percutaneous-coronary-intervention/coroventis-coroflow/important-safety-information.html

Important Safety Information for Coroventis CoroFlow Contraindications: The system has no patient alarm functions. Do not use for cardiac/vital signs monitoring. Warnings: If CoroFlow‡ is used together with 3rd ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K201881.pdf

K201881 Trade/De - accessdata.fda.gov The CoroFlow™ Cardiovascular system is equivalent to QUANTIEN™ Measurement System. (K183099) in terms of intended use and the non-clinical data ...

8. coroventis.com coroventis.com/wp-content/uploads/2024/02/CoroFlow-3.6-IFU-EN-R8.8.pdf

COROFLOW™ INSTRUCTIONS FOR USE CoroFlow™ Cardiovascular System is a system used to collect, calculate, present and store physiological parameters measured by Abbott Medical's. PressureWire ...