The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL, United Kingdom
NCT Number: NCT03097172
This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries.
When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down.
The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.
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Notify Me18 year and older
All sexes
Observational
Basildon, Essex, SS16 5NL, United Kingdom
The study will contain two groups:
Group 1 - stable elective patients with stenotic coronary arteries. These patients are referred as outpatients for a 'pressure wire' test.
Group 2 - stable elective patients with a chronic total occlusion of an artery (CTO). The artery will be either the left anterior descending artery (LAD) or right coronary artery (RCA)
Group 1 - 30 patients
Patients will be recruited from referrals to the centre for a pressure wire study. Participants will be screened for eligibility using the protocol inclusion and exclusion criteria. Study information will be given and informed consent obtained.
Patients will start the procedure prone. A physiology wire will be placed in the artery of interest and measurements taken. Patients will then be turned into the standard supine position with repeat measurements. The study is now completed. The usual pressure measurements will be taken and used to guide treatment as per standard protocol.
Group 2 - 20 patients
Patients will be recruited from referrals to the centre for a percutaneous coronary intervention (PCI) to a chronic total occlusion (CTO). Participants will be screened for eligibility using the protocol inclusion and exclusion criteria. Study information will be given and informed consent obtained.
Patients will undergo CTO PCI as per standard procedure. Once completed, the vessel will be occluded using balloon inflation. Physiological measurements will be taken distal to the occluded balloon. The patient will then be turned prone and repeat measurements again with balloon occlusion will be taken.
This group will have MRI scanning as part of standard care before the procedure. The study will carry out a further MRI, this time in the prone position before PCI as part of the study protocol
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Group 1
Inclusion criteria
Exclusion criteria
Group 2
Inclusion criteria
Exclusion criteria
Time frame: 5 minutes
Changes in coronary physiology in the same vessel when comparing prone and supine patient position
Time frame: 4 weeks
To observe any difference in ischaemia assessment when comparing prone and supine MRI
Mid and South Essex NHS Foundation Trust
Other
Acronym: GRAVITY
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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.
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