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Imaging Coronary Microvascular Dysfunction (CMD) Study

ConditionsAnginaNon-obstructive Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    A treadmill exercise stress study

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Patients with INOCAExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

Number of ER admissions for chest pain per participant

The number of ER admissions for chest pain per participant.

Time frame
3 months

Secondary outcomes

1

The Bruce protocol score

Sub group: Treadmill Exercise Stress Test to obtain mean values of exercise capacity (metabolic equivalents, METs) will be assessed for patients with and without CMD as defined on PET. The Bruce protocol for exercise test uses a series of calculations to determine a subject's score. This score then indicates physical fitness and the presence of coronary heart disease. The Bruce protocol uses the following calculations: VO2max (ml/kg/min) = 14.76 - (1.379 × T) + (0.451 × T²) - (0.012 × T³) Women: VO2max (ml/kg/min) = 2.94 x T + 3.74 Young Women: VO2max (ml/kg/min) = 4.38 × T - 3.9 Men: VO2max (ml/kg/min) = 2.94 x T + 7.65 Young Men: VO2max (ml/kg/min) = 3.62 x T + 3.91.

Time frame
within 3 months of patient enrollment
2

Number of participants with METs >=10 METS

Prevalence of CMD will be assessed among patients with preserved (METs \>=10 METS) and reduced exercise capacity.

Time frame
within 3 months of patient enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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