Table of contents
- Trial overview
- Conditions studied
- Main endpoints and what they mean
- Trial designs, phases, and enrollment
- Who the trials are for
- How Acetylcholine Chloride is used in the studies
- Key trial examples
Trial overview
These studies investigate Acetylcholine Chloride as part of clinical testing for blood vessel function, especially when doctors want to see whether vessels spasm or how well small vessels respond.[1][3] The trials are not all asking the same question: some look at diagnosis or testing methods, while others look at patient outcomes such as angina symptoms and quality of life.[1][3]
The studies in the source data include Phase 2, Phase 3, and Phase 4 research, with both authorised and completed trials.[1][5] Enrollment ranges from a single-person method study to larger studies with 100 to 145 participants.[1][4]
Conditions studied
The main conditions in these trials are vasospastic angina, coronary vasospasm, coronary vasomotor dysfunction, heart failure with preserved ejection fraction, myocardial infarction with non-obstructive coronary arteries (MINOCA), and vascular dysfunction.[1][2][3][4][5]
One trial focuses on people with unequivocal epicardial and/or microvascular vasospastic angina, which means clear spasm in large heart arteries, small heart vessels, or both.[1] Another trial studies patients with MINOCA and looks at whether a precision-medicine approach may improve outcomes after a heart attack without major artery blockage.[3]
Another study includes people with heart failure with preserved ejection fraction, a condition where the heart pumps but does not relax normally.[2] A small method study examines vascular dysfunction and compares blood flow testing approaches.[4]
Main endpoints and what they mean
The primary outcome is the main result a trial wants to measure.[1][2][3][4][5] In these studies, the primary outcomes include blood flow measures, angina symptoms, quality of life, and whether spasm is present on repeat testing.[1][2][3][4][5]
One trial measures the difference in cutaneous microvascular conductance, which is a skin blood flow measure, during acetylcholine iontophoresis after placebo and vericiguat periods.[1] The same study also measures the difference in daily angina episodes recorded on the ORBITA-app.[1]
Another study measures cutaneous vascular conductance in the forearm skin by LASCA during iontophoresis of acetylcholine, insulin, and nitroprusside.[2] The PROMISE study measures angina status and quality of life using the Seattle Angina Questionnaire at 1-year follow-up.[3]
The method study measures forearm blood flow using venous occlusion plethysmography, which is a classic way to measure how much blood flows through the forearm.[4] The EDIT-CAS study defines success as no epicardial vasospasm on repeat spasm provocation testing at 10 weeks.[5]
Trial designs, phases, and enrollment
The studies are interventional trials, which means the researchers actively assign a treatment, test, or comparison instead of only observing patients.[1][2][3][4][5] The phases include Phase 2, Phase 3, and Phase 4, so the research covers early testing, larger studies, and later follow-up research.[1][2][3][4][5]
Enrollment is small in some trials and larger in others. The smallest study includes 1 participant, while the largest listed study includes 145 participants.[3][4] This suggests that some trials are mainly method checks, while others are designed to test clinical benefit in more patients.[4][5]
Who the trials are for
The target populations are people with specific heart and blood vessel problems, especially vasospastic angina and coronary vasospasm.[1][5] Some studies also include people with heart failure with preserved ejection fraction or MINOCA, showing that Acetylcholine Chloride is being used in different clinical settings where blood vessel function matters.[2][3]
One study requires previously proven epicardial vasospasm on acetylcholine reactivity testing and ongoing angina-like symptoms.[5] Another study focuses on patients with documented vasospastic angina pectoris and measures microvascular function before and after treatment periods.[1]
How Acetylcholine Chloride is used in the studies
In these trials, Acetylcholine Chloride is used during vascular testing, often by iontophoresis or by intraarterial use.[1][2][3][4][5] Iontophoresis means the substance is delivered through the skin with a small electrical current, while intraarterial use means it is given into an artery.[1][3][4][5]
The studies use Acetylcholine Chloride to help assess how blood vessels react, especially whether they narrow in a spasm or whether blood flow changes in the skin or forearm.[1][2][4][5] In the source data, it is part of a testing strategy rather than the main treatment in every study.[1][3][5]
Key trial examples
NCT06415227 studies vericiguat in people with unequivocal epicardial and/or microvascular vasospastic angina, and it measures skin microvascular conductance and daily angina episodes during treatment periods that include placebo and vericiguat.[1]
2022-501682-45-00 studies empagliflozin in heart failure with preserved ejection fraction and measures skin blood flow by LASCA during iontophoresis of acetylcholine, insulin, and nitroprusside.[2]
2024-518724-72-00 studies patients with MINOCA and looks at angina status and quality of life at 1 year, using Acetylcholine Chloride as part of the trial’s diagnostic and treatment strategy.[3]
2023-503908-87-00 is a very small method study in vascular dysfunction that compares acetylcholine and carbachol for measuring forearm blood flow.[4]
2023-507782-25-00 studies coronary vasomotor dysfunction and coronary vasospasm, and its main outcome is whether repeat spasm testing shows no epicardial vasospasm after 10 weeks.[5]
