AnginaNCT05634031
Imaging Coronary Microvascular Dysfunction (CMD) Study
A study testing PET imaging, Coronary CT angiogram and Functional Angiography in people with Angina and Non-obstructive Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina, Non-obstructive Coronary Artery Disease
- What is being tested?
- PET imaging, Coronary CT angiogram and Functional Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Morningside
New York, New York, 10025
Krishna Patel, MBBS, MSc
Jagat Narula, MD, PhD
About this study
Official title: Development and Validation of a Non-invasive Algorithm for Diagnosis of Microvascular Angina Among Patients With Ischemia and Non-obstructive Coronary Artery Disease (IMAGING-CMD Study)
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.
Read the detailed description
All patients will be consented and will undergo Rb-82 rest-stress myocardial perfusion imaging PET with flow quantitation using vasodilator (regadenoson preferred) stressor and cold pressor test and an exercise treadmill test according to standard modified Bruce protocol (if able to exercise).
Only the patients who do not have a recent coronary CT angiography will be consented for undergoing a coronary CT angiography for measurement of plaque burden and quantification of extent and degree of epicardial stenosis.
A small subset of patients who have abnormal flow parameters on PET will be invited to participate in the invasive angiographic validation cohort and will undergo an invasive functional angiography with measurement of FFR, CFR, IMR and Ach-vasoreactivity testing to obtain validation data for PET-guided diagnosis of CMD. A short questionnaire of symptom, suspected diagnosis and planned management will be administered to the treating physician prior to and post-study enrollment.
Patient risk factors, symptoms, health status, medications will be collected using standardized data collection form on study enrollment.
For Aim 2, the cardiac PET findings will be made available to the treating clinician.
A positive PET result for endothelial-independent CMD will be defined as global MBFR <2. A positive PET result for endothelial-dependent CMD will be defined as MBF with cold-pressor test <=40%.
If there was evidence of CMD on cardiac PET, specific treatment recommendations will be made available to the treating physician. These recommendations will include consideration of aspirin, statin and ACE-inhibitors in all patients, beta-blockers (eg: carvedilol 6.25 mg BID with uptitration) as first line, non-dihydropyridine calcium channel blockers (cardizem and verapamil) as second line, and amlodipine (in combination with beta-blocker) or ranolazine as third-line therapy.
Patient symptoms and health status and downstream resource utilization (ER admissions for chest pain, use of other invasive or non-invasive diagnostic procedures for CAD) will be collected at 3 months.
Invasive physiology measurements will be made available to the treating clinician along with recommended management based on INOCA endotype (corMICA trial treatment algorithm) at completion of 3 months.
- Conditions
- Angina, Non-obstructive Coronary Artery Disease
- Being tested
- PET imaging, Coronary CT angiogram, Functional Angiography, Treadmill exercise stress study
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imagingRadiation
PET imaging visit, which will take approximately 1-2 hours.
Coronary CT angiogramRadiation
A coronary CT angiogram if the participant has not had one recently.
Functional AngiographyProcedure or surgery
Also called coronary reactivity test, CRT
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 studyProcedure or surgery
A treadmill exercise stress study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: PET imaging; Radiation: Coronary CT angiogram; Procedure: Functional Angiography; Procedure: Treadmill exercise stress study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Number of ER admissions for chest pain per participant
The number of ER admissions for chest pain per participant.
Measured: 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
Measured: 3 months
Secondary outcomes (2)
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.
Measured: within 3 months of patient enrollment
Number of participants with METs >=10 METS
Prevalence of CMD will be assessed among patients with preserved (METs >=10 METS) and reduced exercise capacity.
Measured: within 3 months of patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start26 Apr 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishna Patel, Icahn School of Medicine at Mount Sinai
- Investigators
- Krishna Patel, MBBS, MSc, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634031
- Sponsor's protocol ID
- STUDY-22-00774
- Other IDs
- IF2779994
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Non-invasive Algorithm for Diagnosis of Microvascular Angina Among Patients With Ischemia and Non-obstructive Coronary Artery Disease (IMAGING-CMD Study)
- ClinicalTrials.gov ID
- NCT05634031
- Acronym / sponsor ID
- STUDY-22-00774
- Conditions
- Angina, Non-obstructive Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All patients will be consented and will undergo Rb-82 rest-stress myocardial perfusion imaging PET with flow quantitation using vasodilator (regadenoson preferred) stressor and cold pressor test and an exercise treadmill test according to standard modified Bruce protocol (if able to exercise).
Only the patients who do not have a recent coronary CT angiography will be consented for undergoing a coronary CT angiography for measurement of plaque burden and quantification of extent and degree of epicardial stenosis.
A small subset of patients who have abnormal flow parameters on PET will be invited to participate in the invasive angiographic validation cohort and will undergo an invasive functional angiography with measurement of FFR, CFR, IMR and Ach-vasoreactivity testing to obtain validation data for PET-guided diagnosis of CMD. A short questionnaire of symptom, suspected diagnosis and planned management will be administered to the treating physician prior to and post-study enrollment.
Patient risk factors, symptoms, health status, medications will be collected using standardized data collection form on study enrollment.
For Aim 2, the cardiac PET findings will be made available to the treating clinician.
A positive PET result for endothelial-independent CMD will be defined as global MBFR <2. A positive PET result for endothelial-dependent CMD will be defined as MBF with cold-pressor test <=40%.
If there was evidence of CMD on cardiac PET, specific treatment recommendations will be made available to the treating physician. These recommendations will include consideration of aspirin, statin and ACE-inhibitors in all patients, beta-blockers (eg: carvedilol 6.25 mg BID with uptitration) as first line, non-dihydropyridine calcium channel blockers (cardizem and verapamil) as second line, and amlodipine (in combination with beta-blocker) or ranolazine as third-line therapy.
Patient symptoms and health status and downstream resource utilization (ER admissions for chest pain, use of other invasive or non-invasive diagnostic procedures for CAD) will be collected at 3 months.
Invasive physiology measurements will be made available to the treating clinician along with recommended management based on INOCA endotype (corMICA trial treatment algorithm) at completion of 3 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with INOCA | Experimental | Radiation: PET imaging, Radiation: Coronary CT angiogram, Procedure: Functional Angiography, Procedure: Treadmill exercise stress studyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET imagingPET imaging visit, which will take approximately 1-2 hours. | Radiation | Patients with INOCA |
| Coronary CT angiogramA coronary CT angiogram if the participant has not had one recently. | Radiation | Patients with INOCA |
| Functional AngiographyAlso: coronary reactivity test, CRTA 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. | Procedure or surgery | Patients with INOCA |
| Treadmill exercise stress studyA treadmill exercise stress study | Procedure or surgery | Patients with INOCA |
Primary outcome
The Seattle Angina Questionnaire (SAQ)
Time frame: 3 months
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.
Rose Dyspnea Scale (RDS)
Time frame: 3 months
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.
Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS)
Time frame: 3 months
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.
Number of ER admissions for chest pain per participant
Time frame: 3 months
The number of ER admissions for chest pain per participant.
Number of use of other invasive or non-invasive diagnostic procedures for CAD
Time frame: 3 months
The number of use of other invasive or non-invasive diagnostic procedures for CAD
2 secondary outcomes
The Bruce protocol score
Time frame: within 3 months of patient enrollment
Number of participants with METs >=10 METS
Time frame: within 3 months of patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krishna Patel, MBBS, MSc principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imaging, Coronary CT angiogram and Functional Angiography in people with Angina and Non-obstructive Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikhil K Sirga ((203) 455-6420, NikhilKumar.Sirga@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Seattle Angina Questionnaire (SAQ) (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.