Imaging Coronary Microvascular Dysfunction (CMD) Study

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05634031
Status
Recruiting
Apply to this trial

Conditions

  • Angina
  • Non-obstructive Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PET imaging — RADIATION
    PET imaging visit, which will take approximately 1-2 hours.
  • Coronary CT angiogram — RADIATION
    A coronary CT angiogram if the participant has not had one recently.
  • 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.
  • Treadmill exercise stress study — PROCEDURE
    A treadmill exercise stress study

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
Apr 2025
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with INOCA
    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.

Primary Outcome Measure

The Seattle Angina Questionnaire (SAQ) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai MorningsideNew YorkNew York10025
Krishna Patel, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Jagat Narula, MD, PhD (SUB_INVESTIGATOR)
Leslee Shaw, PhD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Morningside· New York, NY

Related Studies