Coronary Epicardial and Microcirculatory Determinants of Ventricular Tachycardia Tolerability
Study explores heart's response to rapid rhythms in coronary artery disease patients
Plain English Summary
Coronary Flow During Rapid Heart Rates is a Not Applicable clinical trial sponsored by Imperial College London studying Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction, Coronary Microvascular Disease. This study tests how the heart's blood vessels handle fast heart rates, specifically in people with coronary artery disease. It's for patients who are already scheduled for a heart procedure called coronary angiography or angioplasty. Participation involves having measurements taken during the procedure, including blood pressure and blood flow in the heart's arteries, while the heart rate is temporarily increased. There are no alternative treatments being tested; this is an observational study to understand existing conditions. The trial aims to enroll 70 participants.
Official Summary
The goal of this observational study is to learn about the factors which determine how well ventricular tachycardia (VT) is tolerated. The main questions it aims to answer are: 1. What impact does coronary artery disease have on the ability for a patient to tolerate VT? 2. Does treatment of coronary artery disease with stents improve the tolerability of VT? Participants who are undergoing a clinically indicated coronary angiogram or coronary angioplasty procedure will have measurements of blood pressure, coronary pressure and coronary flow made during pacing at a range of heart rates.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are able to give consent and are scheduled for a coronary angiography or angioplasty. You cannot join if you are pregnant or breastfeeding, have unstable coronary artery disease (like a recent heart attack), severe blockages in multiple heart arteries requiring bypass surgery, severe heart valve problems, or very severe heart failure. Age is not specified as a strict criterion, but suitability for the procedure is key. You must have a condition that requires coronary angiography or angioplasty. This trial is studying Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction, Coronary Microvascular Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how blood flow and blood pressure change in the heart's arteries when the heart beats very fast, both before and after procedures like stenting, to see how well the heart The specific primary outcome measures are: Change in coronary flow in participants with different levels of coronary microvascular function. (At baseline and during simulated VT); Change in coronary flow in participants immediately before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI); Change in blood pressure in participants with different levels of coronary microvascular function. (At baseline and during simulated VT); Change in blood pressure in participants before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to understand why some patients tolerate dangerously fast heart rhythms (ventricular tachycardia) better than others, potentially leading to better management of hea This research targets Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction, Coronary Microvascular Disease, where improved treatment options are needed.
Investor Insight
This observational study provides insights into the physiological mechanisms underlying ventricular tachycardia tolerability in coronary artery disease, informing potential future therapeutic targets
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the specific risks of the measurements are. Participation means you will have extra measurements taken during your scheduled heart procedure, which may slightly extend the time you are in the procedure room. You will not receive any new treatments as part of this study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 70 participants
Interventions
- DIAGNOSTIC_TEST: Pressure and flow measurement during simulated VT — Participants undergoing coronary angiography will have measurements of blood pressure, coronary pressure and coronary flow during simulated VT. VT will be simulated using pacing at a range of heart rates.
Primary Outcomes
- Change in coronary flow in participants with different levels of coronary microvascular function. (At baseline and during simulated VT)
- Change in coronary flow in participants immediately before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI)
- Change in blood pressure in participants with different levels of coronary microvascular function. (At baseline and during simulated VT)
- Change in blood pressure in participants before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI)
Secondary Outcomes
- Change in coronary flow in participants with different levels of left ventricular function (At baseline and during simulated VT)
- Change in blood pressure in participants with different levels of left ventricular function (At baseline and during simulated VT)
Full Eligibility Criteria
Inclusion Criteria: * Able to give valid consent * Referred for coronary angiography or coronary angioplasty * Suitable for percutaneous physiological interrogation and PCI when clinically indicated Exclusion Criteria: * Unable to give valid consent * Pregnant or breastfeeding women * Unstable coronary artery disease (acute coronary syndrome) * Severe multivessel coronary artery disease suitable for coronary artery bypass grafting * Severe heart valve disease * Severe (NYHA IV) heart failure
Trial Locations
- Imperial College NHS Foundation Trust, London, United Kingdom
Frequently Asked Questions
What is clinical trial NCT05841199?
NCT05841199 is a Not Applicable OBSERVATIONAL study titled "Coronary Flow During Rapid Heart Rates." It is currently recruiting and is sponsored by Imperial College London. The trial targets enrollment of 70 participants.
What conditions does NCT05841199 study?
This trial investigates treatments for Ventricular Tachycardia, Coronary Artery Disease, Heart Failure, Coronary Microvascular Dysfunction, Coronary Microvascular Disease. The primary condition under study is Ventricular Tachycardia.
What treatments are being tested in NCT05841199?
The interventions being studied include: Pressure and flow measurement during simulated VT (DIAGNOSTIC_TEST). Participants undergoing coronary angiography will have measurements of blood pressure, coronary pressure and coronary flow during simulated VT. VT will be simulated using pacing at a range of heart rates.
What does Not Applicable mean for NCT05841199?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05841199?
This trial is currently "Recruiting." It started on 2023-08-01. The estimated completion date is 2026-06-02.
Who is sponsoring NCT05841199?
NCT05841199 is sponsored by Imperial College London. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05841199?
The trial aims to enroll 70 participants. The trial is currently recruiting and accepting new participants.
How is NCT05841199 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05841199?
The primary outcome measures are: Change in coronary flow in participants with different levels of coronary microvascular function. (At baseline and during simulated VT); Change in coronary flow in participants immediately before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI); Change in blood pressure in participants with different levels of coronary microvascular function. (At baseline and during simulated VT); Change in blood pressure in participants before and after PCI (At baseline and during simulated VT, immediately before PCI and after PCI). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05841199 being conducted?
This trial is being conducted at 1 site, including London (United Kingdom).
Where can I find official information about NCT05841199?
The official record for NCT05841199 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05841199. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05841199 testing in simple terms?
This study tests how the heart's blood vessels handle fast heart rates, specifically in people with coronary artery disease. It's for patients who are already scheduled for a heart procedure called coronary angiography or angioplasty.
Why is this trial significant?
This trial matters because it aims to understand why some patients tolerate dangerously fast heart rhythms (ventricular tachycardia) better than others, potentially leading to better management of hea
What are the potential risks of participating in NCT05841199?
The main risks are related to the coronary angiography or angioplasty procedure itself, such as bleeding, bruising, or allergic reaction to contrast dye. There's a small risk of damage to the blood vessel or heart during the procedure. The temporary increase in heart rate during measurements could potentially cause discomfort or symptoms if your heart cannot tolerate it well. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05841199?
Ask your doctor if this study is right for you and what the specific risks of the measurements are. Participation means you will have extra measurements taken during your scheduled heart procedure, which may slightly extend the time you are in the procedure room. You will not receive any new treatments as part of this study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05841199 signal from an investment perspective?
This observational study provides insights into the physiological mechanisms underlying ventricular tachycardia tolerability in coronary artery disease, informing potential future therapeutic targets This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves having measurements taken during the procedure, including blood pressure and blood flow in the heart's arteries, while the heart rate is temporarily increased. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Ventricular Tachycardia Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.