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NCT05634031 · ClinicalTrials.gov registry record · NA
Imaging Coronary Microvascular Dysfunction (CMD) Study
A NA study of Angina and Non-obstructive Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05634031: Recruiting NA study of Angina and Non-obstructive Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05634031 is a NA study of Angina and Non-obstructive Coronary Artery Disease that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 70 participants, below the 10,672-participant average among 4 other Angina trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05634031, a NA study of Angina and Non-obstructive Coronary Artery Disease, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- RADIATION PET imaging
- RADIATION Coronary CT angiogram
- PROCEDURE Functional Angiography
- PROCEDURE Treadmill exercise stress study
Study Locations (1)
New York
- Mount Sinai Morningside - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-03-01 |
| Phase | NA |
What NCT05634031 shows while recruiting
NCT05634031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 10,672-participant average among 4 other Angina trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Angina appearing as the primary indexed condition, and to 4 interventions - of which PET imaging is the first listed.
NCT05634031 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05634031 about?
NCT05634031 is a clinical study titled "Imaging Coronary Microvascular Dysfunction (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 a...
What is the current status of trial NCT05634031?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2023-04-26. Estimated completion is 2027-03-01.
What conditions does trial NCT05634031 study?
This clinical trial studies the following conditions: Angina, Non-obstructive Coronary Artery Disease.
What interventions are being tested in trial NCT05634031?
The interventions under investigation include: PET imaging (RADIATION), Coronary CT angiogram (RADIATION), Functional Angiography (PROCEDURE), Treadmill exercise stress study (PROCEDURE).
Who is sponsoring clinical trial NCT05634031?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05634031 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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