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Trial record 3 of 261364 for:    ALL

coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants (MATCHY)

This study is not yet open for participant recruitment.
Verified December 2017 by Ya-Wei Xu, Shanghai 10th People's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03372616
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital
  Purpose
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.

Condition Intervention
Healthy Volunteer 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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: coMparison Between invAsive and Non-invasive assessmenT on Blood Pressure and Cardiac Function in HealthY Participants: the MATCHY Study

Resource links provided by NLM:


Further study details as provided by Ya-Wei Xu, Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Aortic blood presure obtained with Sphygmocor device [ Time Frame: 1 day ]
    Sphygmocor device (AtCor Medical, Australia) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

  • Aortic blood presure obtained with PulsePen device [ Time Frame: 1 day ]
    PulsePen device (DiaTecne SRL, Italy) will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

  • Aortic blood presure obtained with Mobil-O-Graph device [ Time Frame: 1 day ]
    Mobil-O-Graph (IEM, Germany) device will be used in non-invasive aortic blood presure measurement with standard protocols shown in its user manual.

  • Aortic blood presure obtained with catheterization [ Time Frame: 1 day ]
    Catheterization will be used in invasive aortic blood presure measurement. The cather will be placed in the aortic root while measuring the blood pressure.


Estimated Enrollment: 100
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Diagnostic Test: Invasive left ventricular diastolic function assessment
Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.
Diagnostic Test: Invasive aortic blood pressure measurement
Aortic blood pressure will be measured with polyethylene catheter in aortic root.
Diagnostic Test: Non-Invasive left ventricular diastolic function assessment
Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.
Diagnostic Test: Non-Invasive aortic blood pressure measurement
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with proposed coronary angiography and left left ventriculography but without diagnosed cardiovascular disease.
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372616


Contacts
Contact: Chen Chi, M.D. 086-150-2178-7802 chichen.david@gmail.com
Contact: Yi Zhang, M.D., Ph.D. 086-189-1768-6332 yizshcn@gmail.com

Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
Study Chair: Yawei Xu, M.D., Ph.D. Shanghai 10th People's Hospital
  More Information

Publications:
Responsible Party: Ya-Wei Xu, Chief director of department of cardiology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03372616     History of Changes
Other Study ID Numbers: MATCHY2017YZ
First Submitted: October 29, 2017
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
aortic blood pressure
diastolic dysfuntion
echocardiography
left ventricular ejection fraction