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CompletedNCT02795377Updated Nov 9, 2017

Hypertension and Injury

An observational study in Arterial Hypertension and CAD, sponsored by Klinik für Kardiologie, Pneumologie und Angiologie. Completed at 1 site in Germany. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by Klinik für Kardiologie, Pneumologie und Angiologie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
50 Years to 80 Years
Sex
Male
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Study summary

Membrane microparticles are submicron fragments of membrane vesicles shed from various cell types. Circulating endothelial microparticles have been proposed as markers of endothelial injury. However, which mechanical forces contribute to their release is not clear.

Read the detailed description

In a first series subjects (50% hypertensives) with and without arterial hypertension and no Coronary Artery Disease (CAD) (n=50) will be recruited. MP subpopulations will be discriminated by flow cytometry according to the expression of established surface antigens including CD31+/41-, CD144+, and CD62e+. Besides office and ambulatory 24h blood pressure measurements, pulse wave analysis will be performed to determine central blood pressure, augmentation index (AIX), and pulse wave velocity. Endothelial function (Flow-mediated dilation, FMD), arterial pulsatile stretch (fractional diameter changes, FDC), and wall-shear-stress (WSS) will be measured in the same segment of the brachial artery (BA) by ultrasound. In a second series, the investigators will take measurements in subjects with hypertensive crises (SBP>180 mmHg) (n=20) before and after 4h and normalization of arterial BP by urapidil. In a third series, the investigators will take measurement in subjects with stable CAD (n=10) before and after transfemoral coronary diagnostic angiography.

02

Conditions studied

  • Arterial Hypertension
  • CAD

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Keywords

  • arterial hypertension
  • microparticle
  • endothelial function
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 80 is below the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with or without arterial hypertension

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male subjects with or without arterial hypertension, hypertensive crises, stable CAD
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • subjects with manifest peripheral artery, or cerebrovascular disease, acute inflammation (CRP>0.6 mg/dl), malignancies, arrhythmias
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • male subjects with arterial hypertension

    Measurements will be taken at baseline.

  • male subjects without arterial hypertension and no CAD

    Measurements will be taken at baseline.

  • male subjects with hypertensive crises

    Measurements will be taken before and after 4 hours and normalization of arterial blood pressure by urapidil.

  • male subjects with stable CAD

    Measurements will be taken before and after transfemoral coronary diagnostic angiography.

06

What researchers measure

Primary outcomes

  1. endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 1 and 2

    Time frame: Baseline

  2. Changes in endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 3

    Time frame: Baseline and after 4 hours

  3. Changes in endothelial function

    endothelial function measured by flow-mediated dilation (FMD) for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

Secondary outcomes

  1. Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 1 and 2

    Time frame: Baseline

  2. Changes in Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 3

    Time frame: Baseline and after 4 hours

  3. Changes Microparticle

    Microparticles (CD31+/41-, CD144+, and CD62e+) will be discriminated by flow cytometry for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

  4. Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 1 and 2

    Time frame: Baseline

  5. Changes in Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 3

    Time frame: Baseline and 4 hours

  6. Changes in Wall Shear Stress

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

  7. changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 1 and 2

    Time frame: Baseline

  8. changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 3

    Time frame: Baseline and after 4 hours

  9. Changes in fractional diameter (FDC)

    measured by ultrasound in brachial artery for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

  10. pulse wave velocity

    measured for Subgroup 1 and 2

    Time frame: Baseline

  11. Changes in pulse wave velocity

    measured for Subgroup 3

    Time frame: Baseline and after 4 hours

  12. Changes in pulse wave velocity

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

  13. augmentation index

    measured for Subgroup 1 and 2

    Time frame: baseline

  14. Changes in augmentation index

    measured for Subgroup 3

    Time frame: Baseline and after 4 hours

  15. Changes in augmentation index

    measured for Subgroup 4 before and after transfemoral coronary diagnostic angiography

    Time frame: Baseline and 4 hours after procedure

07

Study locations

1 site
  • Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,
    Düsseldorf, North Rhine-Westphalia 40225, Germany
08

References and documents

Publications

  • Sansone R, Baaken M, Horn P, Schuler D, Westenfeld R, Amabile N, Kelm M, Heiss C. Release of endothelial microparticles in patients with arterial hypertension, hypertensive emergencies and catheter-related injury. Atherosclerosis. 2018 Jun;273:67-74. doi: 10.1016/j.atherosclerosis.2018.04.012. Epub 2018 Apr 12. PubMed 29684662 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2016
First posted
Jun 10, 2016
Start
Apr 2016
Primary completionActual
Nov 2017
CompletionActual
Nov 2017
Last update
Nov 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02795377
Lead sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible party
Klinik für Kardiologie, Pneumologie und Angiologie (Principal Investigaor, Heinrich-Heine University, Duesseldorf) — Sponsor-investigator
First posted
Jun 10, 2016
Start date
Apr 2016
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Nov 9, 2017

Study contacts

Roberto Sansone, MD
principal investigator · Division of Cardiology, Pulmonary Disease and Vascular Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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