Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05634031
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-11
First Post:
2022-11-21
Brief Title:
Imaging Coronary Microvascular Dysfunction CMD Study
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 625 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
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 625 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IF2779994 | OTHER_GRANT | Jubilant DraxImage Inc | None |