ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
Conditions
Keywords
Coronary Reactivity Testing, Intracoronary Nitroglycerine
Brief summary
This single-arm, multi-center, prospective study will assess the coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and determinants thereof (transit time, Pa, Pd) in patients before and after intracoronary nitroglycerine.
Detailed description
This will be a single arm, multi-center, prospective interventional study. We will approach, consent, and enroll patients referred to the cardiac catheterization laboratory for coronary angiography for the indication of angina without obstructive coronary artery disease (CAD; lesions \<50%, fractional flow reserve (FFR) \>0.80, or non-hyperemic pressure index (RFR) \<0.89). Patients will undergo invasive assessment with CRT first without IC nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat CRT. Approximately 50 patients undergoing coronary angiography for evaluation of ANOCA or INOCA will be consented for this study. The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration. The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates. These variables will be compared to one another using paired t-tests and generalized estimating equations.
Interventions
DIAGNOSTIC_TESTCoronary reactivity testing with and without nitrates
CRT will be performed in the left and right coronary arteries. Measurements will be obtained in each of the coronaries first without intracoronary nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat measurements.
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 or older 2. Patient being evaluated for ANOCA or INOCA 3. Clinical suspicion for angina 4. Patient should be able to comply with the protocol. 5. Provide written informed consent before study participation.
Exclusion criteria
1. Existing coronary artery disease 2. Previous percutaneous interventions within the coronaries 3. Current use (within 48 hours) of long-acting nitrate therapies 4. Current use (within 48 hours) of PDE-5 inhibitors (sildenafil, tadalafil) 5. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study. 6. Children below 18 years, prisoners, pregnant people and patients who are unable to provide consent are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of CFR by CRT before and after nitrates | Intra op | The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates. | Intra op | The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates. |
Countries
United States
Contacts
CONTACTBonnie Ostergren
Outcome results
None listed