Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
Stopped early · Not applicable
Conditions studied: Coronary; Ischemic
In brief
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. There are no follow up visits required so participation in this study will end when subjects are discharged from the hospital.The study will be comparing the resting flow reserve against the instantaneous wave-free ratio (iFR) and fractional flow reserve. All these tests offer a way to image a legion and determine if it is suitable to be treated. FFR measures the pressure differences across (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed in the arteries of the heart that are to be assessed and the Resting flow reserve looks at the maximum increase in blood flow through the coronary arteries above the normal resting volume.
Key facts
- Study ID
- NCT03461705
- Run by
- Columbia University
- People needed
- 5
- Starts
- 2017-10-20
- Expected to finish
- 2018-08-02
- Last updated by the study team
- 2020-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
- Angiographically 40%-90% stenosis present in at least one native coronary artery.
- Undergoing physiological assessment for standard clinical or diagnostic indications
You may not qualify if…
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Left main stenosis
- Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
- Saphenous vein graft, chronic total occlusion
- Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
- Currently participating in another clinical study that interferes with study results.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- High degree A-V block, sinus node disease.
- Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze
- Known hypersensitivity to adenosine
- ST-Elevation Myocardial Infarction (STEMI) within 48 hours.
Where it is running
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.