Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
Location status: Recruiting
Location contact
Bonnie Ostergren
CONTACT
Sarah Hale
CONTACT
NCT Number: NCT06896903
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Plano, Texas, 75093, United States
Location status: Recruiting
Bonnie Ostergren
CONTACT
Sarah Hale
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Intra op
The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration.
Time frame: Intra op
The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates.
Contact information is provided by the study sponsor or research team.
Baylor Research Institute
Other
Acronym: CRT-NITRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07103317
ANOCA, ANOCA - Angina With Non-obstructive Coronary Arteries
Prague, Česká Republika, Czechia
View Trial DetailsNCT07593157
ANOCA - Angina With Non-obstructive Coronary Arteries, Angina Pectoris
Montevideo, Montevideo Department, Uruguay
View Trial DetailsNCT07422818
ANOCA - Angina With Non-obstructive Coronary Arteries
View Trial DetailsNCT06755801
ANOCA - Angina With Non-obstructive Coronary Arteries, Angina Pectoris
View Trial Details