Hypertension and Injury

NCT02795377 | Completed

• 2 other identifiers: Hypertension and Injury12-011
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arterial Hypertension; CAD

Keywords

arterial hypertension; microparticle; endothelial function

Outcome Measures

Primary Outcomes (3)

• endothelial function

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

  Baseline

• Changes in endothelial function

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

  Baseline and after 4 hours

• Changes in endothelial function

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

  Baseline and 4 hours after procedure

Secondary Outcomes (15)

• Microparticle

  Baseline

• Changes in Microparticle

  Baseline and after 4 hours

• Changes Microparticle

  Baseline and 4 hours after procedure

• Wall Shear Stress

  Baseline

• Changes in Wall Shear Stress

  Baseline and 4 hours

Study Arms (4)

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with or without arterial hypertension

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Division of Cardiology, Pulmonology and Vascular Medicine Duesseldorf,

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

• 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.

  PMID: 29684662 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Roberto Sansone, MD

  Division of Cardiology, Pulmonary Disease and Vascular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigaor

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: June 10, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

DE (1)