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Clinical Trials/NCT03097172
NCT03097172
Completed
N/A

The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention

Mid and South Essex NHS Foundation Trust1 site in 1 country22 target enrollmentJune 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Mid and South Essex NHS Foundation Trust
Enrollment
22
Locations
1
Primary Endpoint
Coronary physiology changes
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years of age
  • Angina symptoms or evidence of myocardial ischaemia
  • Stenosis \>50% in LAD or RCA on coronary angiogram or CT coronary angiogram
  • Participant is willing and able to give informed consent
  • Eligible for PCI

Exclusion Criteria

  • Previous CABG with any patent grafts
  • Significant left main stem stenosis
  • Lesion of interest in Circumflex artery
  • Haemodynamic Instability
  • Unable to consent
  • Unable to receive dual antiplatelet therapy
  • Contraindication to adenosine
  • Recent acute coronary syndrome (ACS) (\<48 hours)
  • Unable to lie prone
  • Severe valvular heart disease or cardiomyopathy

Outcomes

Primary Outcomes

Coronary physiology changes

Time Frame: 5 minutes

Changes in coronary physiology in the same vessel when comparing prone and supine patient position

Secondary Outcomes

  • MRI finding(4 weeks)

Study Sites (1)

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