Imaging Coronary Microvascular Dysfunction (CMD) Study

NCT05634031 | Recruiting

• 2 other identifiers: STUDY-22-00774IF2779994
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million people in the United States alone, and 112 million people globally. Despite this, 4 in 10 patients undergoing elective coronary angiography for angina and ischemia do not have evidence of obstructive coronary artery disease (CAD). This condition of ischemia with no obstructive CAD (INOCA) is associated with high clinical and economic morbidity, as these patients have a higher rate of repeat procedures and hospitalizations, worse quality of life, future adverse cardiovascular events and frequent time missed from work. The overall objective of this study is to develop and validate a non-invasive algorithm for diagnosis and management of patients with INOCA and suspected microvascular dysfunction centered around cardiac PET MPI. A secondary goal of the study is to assess for improvement in patient symptoms, function and quality of life from PET-guided management of CMD in patients with INOCA. This study will take place at Mount Sinai Morningside in the PET and CTunit on the 3rd floor. The sub-study will occur at Mount Sinai Morningside Cath Lab on the 3rd floor. The study will enroll an estimated total of 70 subjects, 12 of which will also participate in the sub-study. The study is estimated to last 2 years.

Conditions

Angina; Non-obstructive Coronary Artery Disease

Outcome Measures

Primary Outcomes (5)

• The Seattle Angina Questionnaire (SAQ)

  The Seattle Angina Questionnaire (SAQ) is a 7-item self-administered questionnaire with a 4-week recall period measuring health status in patients with CAD across 3 domains: physical limitation (PL), angina frequency (AF), and quality of life (QoL). Full scale from 0-100, with higher score indicating better health outcome.

  3 months

• Rose Dyspnea Scale (RDS)

  Rose Dyspnea Scale (RDS) is a 4-item questionnaire with a 1-month recall period that assesses patients' level of dyspnea with common activities. Full scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea. Higher score indicates poorer health outcomes.

  3 months

• Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS)

  Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS) The EQ-5D gives a measure of health-related quality of life. The visual analogue score is a measure of overall self-rated health status with full scale from 0-100. Higher scores indicate better health outcomes.

  3 months

• Number of ER admissions for chest pain per participant

  The number of ER admissions for chest pain per participant.

  3 months

• Number of use of other invasive or non-invasive diagnostic procedures for CAD

  The number of use of other invasive or non-invasive diagnostic procedures for CAD

  3 months

Secondary Outcomes (2)

• The Bruce protocol score

  within 3 months of patient enrollment

• Number of participants with METs >=10 METS

  within 3 months of patient enrollment

Study Arms (1)

Patients with INOCA

EXPERIMENTAL

Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease.

Radiation: PET imaging; Radiation: Coronary CT angiogram; Procedure: Functional Angiography; Procedure: Treadmill exercise stress study

Interventions

PET imaging RADIATION

PET imaging visit, which will take approximately 1-2 hours.

Patients with INOCA

Coronary CT angiogram RADIATION

A coronary CT angiogram if the participant has not had one recently.

Patients with INOCA

Functional Angiography PROCEDURE

A subset of patients with abnormal results on cardiac PET myocardial perfusion imaging study (estimated number of patients = 12) will be invited to participate in an invasive sub-study wherein they would undergo detailed invasive coronary physiology evaluation. Functional Angiography (coronary reactivity test- CRT): is an angiography procedure done in the catheterization laboratory. It evaluates the coronary artery microcirculation and how the blood vessels respond to different medications.

Also known as: coronary reactivity test, CRT

Patients with INOCA

Treadmill exercise stress study PROCEDURE

A treadmill exercise stress study

Patients with INOCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms of exertional angina and/or dyspnea (confirmed on Seattle Angina Questionnaire and Rose Dyspnea Questionnaire)
• Evidence of non-obstructive CAD on CCTA or coronary angiography (no stenosis \>50% and/or FFR if performed \>0.80)

You may not qualify if:

• Patients with reduced LVEF (\<50%) or diagnosis of cardiomyopathy
• Patients with co-existent moderate or severe valve disease
• Patients with eGFR \<30 ml/min/m2
• History of prior coronary revascularization
• Non-coronary indication for CCTA or coronary angiogram determining eligibility
• Contraindications to regadenoson (severe asthma/chronic obstructive pulmonary disease, brady-arrhythmias, or systolic blood pressure \<90 mm Hg)
• Inability to provide informed consent
• Pregnancy

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Morningside

New York, New York, 10025, United States

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Krishna Patel, MBBS, MSc

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilia Soriano, BS

CONTACT

(929) 736-1828; lilia.soriano@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Cardiology) and Population Health Science and Policy

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: April 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

US (1)