Healthy VolunteerMATCHYNCT03372616
coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants
An observational study of Healthy Volunteer, run by Shanghai 10th People's Hospital.
Trial summary
This is a cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Invasive left ventricular diastolic function assessment, Invasive aortic blood pressure measurement and Non-Invasive left ventricular diastolic function assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with proposed coronary angiography and left left ventriculography but without diagnosed cardiovascular disease.
Who may be able to join
- Over or equal to 18 years old;
- Agree to participate the study and sign informed written consent;
- Any change of drugs which effect the hemodynamics during 1 month prior to enrollment;
- Proposed to perform coronary angiography and left left ventriculography in hospital;
Who cannot join
- Non-sinus rhythm or frequent extra systoles;
- Identified coronary artery disease via coronary angiography;
- Diagnosed pulmonary vascular or parenchymal disease;
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
- Stenosis or insufficiency of valves (moderate and above);
- Heart transplant;
- Congenital heart disease;
- Inadequate imaging or doppler parameter quality in echocardiography.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study
This is a cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Non-invasive assessment includes echocardiography,aortic, and carotid blood pressure measurement.
- Conditions
- Healthy Volunteer
- Being tested
- Invasive left ventricular diastolic function assessment, Invasive aortic blood pressure measurement, Non-Invasive left ventricular diastolic function assessment, Non-Invasive aortic blood pressure measurement
- Keywords
- aortic blood pressure, diastolic dysfuntion, echocardiography, left ventricular ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive left ventricular diastolic function assessmentDiagnostic test
Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.
Invasive aortic blood pressure measurementDiagnostic test
Aortic blood pressure will be measured with polyethylene catheter in aortic root.
Non-Invasive left ventricular diastolic function assessmentDiagnostic test
Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.
Non-Invasive aortic blood pressure measurementDiagnostic test
Three devices (Sphygmocor [AtCor Medical, Australia], PulsePen [DiaTecne SRL, Italy], and Mobil-O-Graph [IEM, Germany] ) will be used to assess aortic blood pressure non-invasively when participants are undergoing invasive aortic blood pressure measurement.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Aortic blood pressure, LV filling pressrue, and LV volume will be measured in all participants. Meanwhile, echocardiography and non-invasive aortic blood presure measurement will be performed. Three devices will be used in non-invasive aortic blood presure measurement, including Sphygmocor (AtCor Medical, Australia), PulsePen (DiaTecne SRL, Italy), and Mobil-O-Graph (IEM, Germany). In conclusion, all participants will receive invasive and non-invasive left ventricular diastolic function assessment, together with invasive and non-invasive aortic blood pressure assessment. Receives: Diagnostic Test: Invasive left ventricular diastolic function assessment; Diagnostic Test: Invasive aortic blood pressure measurement; Diagnostic Test: Non-Invasive left ventricular diastolic function assessment; Diagnostic Test: Non-Invasive aortic blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular filling pressure assessment with left heart catheterization
All participants will receive invasive left ventricular filling pressure assessment with left heart catheterization.
Measured: 1 day
Left ventricular diastolic function assessment with echocardiography using ASE recommendations
All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The ASE-recommended (American Society of Echocardiography) creteria would be used to define left ventricular diastolic dysfunction.
Measured: 1 day
Left ventricular diastolic function assessment with echocardiography using EACVI recommendations
All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The EACVI-recommended (European Association of Cardiovascular Imaging) creteria would be used to define left ventricular diastolic dysfunction.
Measured: 1 day
Secondary outcomes (4)
Aortic blood presure obtained with Sphygmocor device
Sphygmocor device (AtCor Medical, Australia) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.
Measured: 1 day
Aortic blood presure obtained with PulsePen device
PulsePen device (DiaTecne SRL, Italy) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.
Measured: 1 day
Aortic blood presure obtained with Mobil-O-Graph device
Mobil-O-Graph (IEM, Germany) device will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.
Measured: 1 day
Aortic blood presure obtained with catheterization
Catheterization will be used in invasive aortic blood presure measurement. The cather will be placed in the aortic root while measuring the blood pressure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startJan 2018 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, M.D., Ph.D., Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372616
- Sponsor's protocol ID
- MATCHY2017YZ
- Acronym
- MATCHY
- Status last verified
- Dec 2017
- First submitted
- 29 Oct 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
PubMed 27037982Handoko ML, Paulus WJ. Polishing the diastolic dysfunction measurement stick. Eur J Echocardiogr. 2008 Sep;9(5):575-7. doi: 10.1093/ejechocard/jen181. Epub 2008 Jun 11. No abstract available.
PubMed 18579489McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson IB. Central blood pressure: current evidence and clinical importance. Eur Heart J. 2014 Jul;35(26):1719-25. doi: 10.1093/eurheartj/eht565. Epub 2014 Jan 23.
PubMed 24459197
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study
- ClinicalTrials.gov ID
- NCT03372616
- Acronym / sponsor ID
- MATCHY / MATCHY2017YZ
- Conditions
- Healthy Volunteer
- Keywords
- aortic blood pressure, diastolic dysfuntion, echocardiography, left ventricular ejection fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Dec 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 cross-sectional cohort study which aims to compare the invasive and non-invasive assessments on aortic blood pressure and cardiac funtion in subjects without history of cardio-vascular disease. Left ventricular (LV) filling pressure, LV volume, and aortic blood pressure will be measured invasively. Non-invasive assessment includes echocardiography,aortic, and carotid blood pressure measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Diagnostic Test: Invasive left ventricular diastolic function assessment, Diagnostic Test: Invasive aortic blood pressure measurement, Diagnostic Test: Non-Invasive left ventricular diastolic function assessment, Diagnostic Test: Non-Invasive aortic blood pressure measurementAortic blood pressure, LV filling pressrue, and LV volume will be measured in all participants. Meanwhile, echocardiography and non-invasive aortic blood presure measurement will be performed. Three devices will be used in non-invasive aortic blood presure measurement, including Sphygmocor (AtCor Medical, Australia), PulsePen (DiaTecne SRL, Italy), and Mobil-O-Graph (IEM, Germany). In conclusion, all participants will receive invasive and non-invasive left ventricular diastolic function assessment, together with invasive and non-invasive aortic blood pressure assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proposed coronary angiography and left left ventriculography but without diagnosed cardiovascular disease.
Key inclusion criteria (4 listed)
- Over or equal to 18 years old;
- Agree to participate the study and sign informed written consent;
- Any change of drugs which effect the hemodynamics during 1 month prior to enrollment;
- Proposed to perform coronary angiography and left left ventriculography in hospital;
Key exclusion criteria (8 listed)
- Non-sinus rhythm or frequent extra systoles;
- Identified coronary artery disease via coronary angiography;
- Diagnosed pulmonary vascular or parenchymal disease;
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
- Stenosis or insufficiency of valves (moderate and above);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive left ventricular diastolic function assessmentLeft ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure. | Diagnostic test | All participants |
| Invasive aortic blood pressure measurementAortic blood pressure will be measured with polyethylene catheter in aortic root. | Diagnostic test | All participants |
| Non-Invasive left ventricular diastolic function assessmentEchocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively. | Diagnostic test | All participants |
| Non-Invasive aortic blood pressure measurementThree devices (Sphygmocor [AtCor Medical, Australia], PulsePen [DiaTecne SRL, Italy], and Mobil-O-Graph [IEM, Germany] ) will be used to assess aortic blood pressure non-invasively when participants are undergoing invasive aortic blood pressure measurement. | Diagnostic test | All participants |
Primary outcome
Left ventricular filling pressure assessment with left heart catheterization
Time frame: 1 day
All participants will receive invasive left ventricular filling pressure assessment with left heart catheterization.
Left ventricular diastolic function assessment with echocardiography using ASE recommendations
Time frame: 1 day
All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The ASE-recommended (American Society of Echocardiography) creteria would be used to define left ventricular diastolic dysfunction.
Left ventricular diastolic function assessment with echocardiography using EACVI recommendations
Time frame: 1 day
All participants will receive non-invasive left ventricular diastolic function assessment with echocardiography. The EACVI-recommended (European Association of Cardiovascular Imaging) creteria would be used to define left ventricular diastolic dysfunction.
4 secondary outcomes
Aortic blood presure obtained with Sphygmocor device
Time frame: 1 day
Aortic blood presure obtained with PulsePen device
Time frame: 1 day
Aortic blood presure obtained with Mobil-O-Graph device
Time frame: 1 day
Aortic blood presure obtained with catheterization
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Background: PubMed 27037982Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.
- Background: PubMed 18579489Handoko ML, Paulus WJ. Polishing the diastolic dysfunction measurement stick. Eur J Echocardiogr. 2008 Sep;9(5):575-7. doi: 10.1093/ejechocard/jen181. Epub 2008 Jun 11. No abstract available.
- Background: PubMed 24459197McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson IB. Central blood pressure: current evidence and clinical importance. Eur Heart J. 2014 Jul;35(26):1719-25. doi: 10.1093/eurheartj/eht565. Epub 2014 Jan 23.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Yawei Xu, M.D., Ph.D. study chair
Shanghai 10th People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Shanghai 10th People's Hospital.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Chi, M.D. (086-150-2178-7802, chichen.david@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular filling pressure assessment with left heart catheterization (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372616, which also lists 3 linked publications.
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 13 Dec 2017.