Coronary Artery DiseaseGRAVITYNCT03097172
The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention
An observational study of Coronary Artery Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the centre for 'pressure wire study' (group 1) or CTO PCI (group 2). Referred from secondary care to tertiary centre. Participants will be patients suffering from ischaemic heart disease living in the area served by the tertiary centre
Who may be able to join
- 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
- Age >18 years of age
Show all 11Show fewer
- Stable angina / ischaemic symptoms / and / or
- Evidence of viability and /or ischaemia in the chronic total occlusion (CTO) territory
- Participant is willing and able to give informed consent.
- Presence of chronic total occlusion (CTO) in LAD or RCA
- Eligible for PCI to a chronic total occlusion (CTO)
Who cannot join
- 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
Show all 25Show fewer
- Contraindication to adenosine
- Recent acute coronary syndrome (ACS) (<48 hours)
- Pregnancy
- Unable to lie prone
- Severe valvular heart disease or cardiomyopathy
- Group 2
- Previous CABG with any patent grafts
- Significant left main stem stenosis
- Dominant collateral supply from circumflex artery
- Both LAD and RCA occluded
- Haemodynamic instability
- Unable to receive antiplatelet therapy
- Contraindication to adenosine
- Recent ACS (<48 hours)
- eGFR<40
- Pregnancy
- Severe valvular heart disease or cardiomyopathy
- Contraindication to Cardiac MRI
- Unable to lie prone
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
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.
Read the 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
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention (PCI), Chronic Total Occlusion (CTO), Cardiac MRI, Fractional Flow Reserve (FFR), Doppler Flow Velocity, Cardiovascular Disease, Atherosclerosis, Hydrostatic Pressure
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Stable elective patients Stenotic coronary artery 10 x LAD 10 x RCA 10 x Cx 30 patients total | |
| Group 2 | Stable elective patients Chronic total occlusion of one artery 10 x LAD 10 x RCA 20 patients total |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary physiology changes
Changes in coronary physiology in the same vessel when comparing prone and supine patient position
Measured: 5 minutes
Secondary outcomes (1)
MRI finding
To observe any difference in ischaemia assessment when comparing prone and supine MRI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Sponsor
- Investigators
- John R Davies, MBBS, PhD, Principal investigator, Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097172
- Sponsor's protocol ID
- B905
- Acronym
- GRAVITY
- Status last verified
- Dec 2020
- First submitted
- 27 Mar 2017
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention
- ClinicalTrials.gov ID
- NCT03097172
- Acronym / sponsor ID
- GRAVITY / B905
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention (PCI), Chronic Total Occlusion (CTO), Cardiac MRI, Fractional Flow Reserve (FFR), Doppler Flow Velocity, Cardiovascular Disease, Atherosclerosis, Hydrostatic Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Stable elective patients Stenotic coronary artery 10 x LAD 10 x RCA 10 x Cx 30 patients total |
| Group 2 | – | –Stable elective patients Chronic total occlusion of one artery 10 x LAD 10 x RCA 20 patients total |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the centre for 'pressure wire study' (group 1) or CTO PCI (group 2). Referred from secondary care to tertiary centre. Participants will be patients suffering from ischaemic heart disease living in the area served by the tertiary centre
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (25 listed)
- Previous CABG with any patent grafts
- Significant left main stem stenosis
- Lesion of interest in Circumflex artery
- Haemodynamic Instability
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary physiology changes
Time frame: 5 minutes
Changes in coronary physiology in the same vessel when comparing prone and supine patient position
1 secondary outcome
MRI finding
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Davies, MBBS, PhD principal investigator
Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary physiology changes (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.