- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258228
Transcoronary Pacing and Myocardial Viability
Trans-coronary Pacing to Assess Myocardial Viability
Narrowing of the coronary arteries can cause chest pain and weaken the heart. In patients who have had heart attacks, blocked or severely narrowed arteries should be investigated (with coronary artery x-rays, or angiography) with efforts undertaken to improve the blood flow (angioplasty and stenting or heart bypass surgery). Sometimes these arteries are in fact supplying heart tissue which is already dead. Procedures to open up these vessels will therefore not influence how the patient feels or their future prognosis. On occasion, in order to determine whether heart tissue is alive (viable) and likely to benefit from of such efforts, a further investigation is required before another attempt is undertaken to open up these diseased arteries. This will require imaging of the heart to assess the state of the tissue (for example with magnetic resonance imaging, or cardiac MRI which is the gold standard). This means that patients may require two invasive procedures. One way around this would be to assess the electrical properties of the heart muscle in question during a single procedure. The principle is simply that dead muscle will have no electrical activity. Assessing the electrical properties of the heart through the coronary arteries using the same equipment used to treat the diseased artery during initial coronary angiography may provide viability information instantly, thus allowing treatment to proceed at the same procedure. In order to investigate whether this approach has promise, we will be performing a cardiac MRI around the time that patients have their coronary angioplasty. The electrical data will be compared to the cardiac MRI results to determine if this technique can be used in clinical practice. This innovative work has potential clinical and financial benefits.
Furthermore, patients can be diagnosed and treated during one procedure
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Leeds, United Kingdom, LS9 7TF
- Recruiting
- Leeds Teaching Hospital NHS Trust
-
Contact:
- Muzahir Tayebjee
- Phone Number: 01132066051
- Email: muzahir.tayebjee@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Out Patients over 18 years who have been listed for electively for percutaneous coronary intervention.
2. In Patients who have been admitted with an acute coronary syndrome undergoing angiography query proceed
Exclusion Criteria:
1. Patients deemed to be in the terminal stage of illness; and patients who are unable to give informed consent.
2. Atrial fibrillation with uncontrolled ventricular response at the time of procedure 3. The presence of a total occlusion of a coronary artery 4. Contra indications to coronary intervention 5. Patients with contraindications for cardiac MRI (See appendix) (15) 6. Patients with prior CABG 7. Patients who are claustrophobic 8. ST elevation myocardial infarction 9. Patients who have pace maker in situ 10. Patients on class I and III antiarrhythmics 11. Patients with haemodynamic instability
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transcoronary mapping
Time Frame: 60 minutes
|
60 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CD19/124706
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Pacing, Artificial
-
Medtronic Cardiac Rhythm and Heart FailureTerminatedCardiac Pacemaker, Artificial | Cardiac Pacing, ArtificialCanada, United States, Israel, Italy, Qatar, China
-
University Hospital, GenevaSwiss National Fund for Scientific ResearchCompletedCardiac Resynchronization Therapy | Cardiac Pacing, Artificial | Direct His Bundle PacingSwitzerland
-
University Hospital Schleswig-HolsteinCompletedCoronary Artery Bypass | Ventricular Function, Left | Cardiac Pacing,ArtificialGermany
-
Shanghai Zhongshan HospitalCompletedHeart Failure | Cardiac Resynchronization Therapy | Cardiac Pacing, ArtificialChina
-
Medical University of ViennaCompletedCohort Studies | Pacemaker, Artificial | Cardiac Pacing, Artificial | Arrhythmias Requiring Therapy
-
Biotronik SE & Co. KGCompletedCardiac Pacing, ArtificialGermany, Israel, Hong Kong, Austria, Czech Republic, Australia, Brazil, Canada, Slovakia, Spain
-
Charles University, Czech RepublicRecruitingVentricular Rhythm From Artificial PacingCzechia
-
University of CalgaryCalgary Health TrustTerminatedAtrial Fibrillation | Cardiac Pacing, ArtificialCanada
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Hoffmann-La Roche; Medtronic; Cambridge...CompletedHeart Failure, Congestive | Cardiac Pacing, Artificial | DefibrillatorsCanada
-
Luzerner KantonsspitalInovise MedicalCompletedHeart Failure, Congestive | Transcutaneous Electric Nerve Stimulation | Cardiac Pacing, ArtificialSwitzerland