Clinical trial NCT05603520: Phenotyping Heterogeneity and Regionality of the Aorta
Official title: Phenotyping Heterogeneity and Regionality of the Aorta
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Large Artery Stiffness
Aortic Disease
Aortic Stenosis
Aortic Aneurysm
Keywords: aortic disease
large artery stiffness
aortic stenosis
aortic aneurysm
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers, patients with aortic stenosis, patients with aortic aneurysm

Brief summary: The aorta distributes cardiac stroke volume into the whole body through its finetuned conductance function, that is propagation and modulation of flow pattern. Physicomechanic properties of the aortic wall assure continuous and homogenous blood flow distribution to organs. The physicomechanic properties of the aortic wall are heterotopic: The collagen/elastin ratio doubles in the abdominal aorta as compared to the thoracic aorta. Malfunction of aortic conduction due to large artery stiffening (LAS) leads to premature wave reflection and excess pulsatility which translate into organ damage in low-resistance beds. The regional heterogeneity of aortic physicomechanic properties and their histomorphological substrate leading to altered regional hemodynamics are not well investigated.

Within the PHaRAo population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from PHaRAo patients. This cohort study is an open-end observational study to identify master switches in aortic disease


Eligibility criteria: 1. apparently healthy volunteers

   Inclusion Criteria:

   • Healthy volunteers

   Exclusion Criteria:
   * \< 18 years
   * Active Medication
   * Cardiovascular Disease
   * MRI not possible
2. Patients with Aortic Stenosis

   Inclusion Criteria:

   • Patients suffering from 3rd drgree Aortic Stenosis

   Exclusion Criteria:
   * \< 18 years
   * MRI not possible
3. Patients with Aortic Aneurysms

Inclusion Criteria:

• Patients suffering from Aortic Aneurysms

Exclusion Criteria:

* \< 18 years
* MRI not possible

Primary outcomes:
measure: Progressive accelerated Large Artery Stiffening
timeFrame: 5 years
measure: Development of Aortic Aneurysm
timeFrame: 5 years
measure: Progressive accelerated Large Artery Stiffening
timeFrame: 5 years
Secondary outcomes:
measure: Diastolic Dysfunction
timeFrame: 5 years
measure: Diastolic Dysfunction
timeFrame: 5 years
measure: Ejection Rate and Ejection Time
timeFrame: 5 years
measure: Ejection Rate and Ejection Time
timeFrame: 5 years
measure: Flow encoded regional MRI metrics
timeFrame: 5 years
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Christine Quast
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Christine Quast, MD
role: PRINCIPAL_INVESTIGATOR
References: