Blood Pressureao_dissNCT01068691
Arterial Properties of Thoracic Aorta Disease
An observational study of Blood Pressure, run by University Hospital, Grenoble at 1 site in France.
Trial summary
A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque rupture via imaging in almost 50% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Jun 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This is a pilot, descriptive and single-centre study.
Who may be able to join
- Male or female patients aged 18 or over who:
- benefit from the French social security system
- will be monitored as outpatients
- have given their written consent to participate in this study
- have been operated over 6 months ago for a type A thoracic AD or AH at Grenoble University Hospital in the period from 1 January 1990 to 30 June 2007
- are able to travel to Grenoble University Hospital
Who cannot join
- Bedridden or reduced mobility patients.
- Patients whose physical or psychological condition could affect their informed consent and compliance with the requirements of the protocol.
- Adult patients protected by the law (article L1121-8 of the French Public Health Code).
- Individuals serving a prison sentence (article L1121-8 of the French Public Health Code).
- Women who are pregnant, have recently given birth or are breastfeeding.
- Patients in the terminal phase of a serious illness.
Show all 10Show fewer
- Individuals serving a prison sentence as a result of a legal or administrative ruling, or individuals receiving legal protection.
- Children.
- Patients taking part in another study.
- Individual who is not part of the social security system or who does not benefit from it.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Grenoble
BAGUET JB Jean-Philippe, Pr
CHAVANON OC Olivier, Pr
About this study
Official title: Blood Pressure Control and Arterial Properties After Surgical Treatment of Type A Thoracic Aortic Dissection or Haematoma
A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque rupture via imaging in almost 50% of cases. AH occurs in older patients than those with AD and develops on atheromatous lesions with parietal ulcers, most often in cases of poorly managed, pre-existing hypertension (HTN). Type A AHs, which affect the ascending aorta, frequently progress towards an AD with a high risk of mortality, and represent a surgical indication.
Patients who have presented AD or AH, whether they have been operated or not, must undergo prolonged monitoring. This involves both clinical and radiological checks to ensure that blood pressure is properly monitored, that the parietal lesions have receded and that there are no complications.
Read more
HTN is a recognized risk factor for the onset of AD and systolic blood pressure must be brought down to between 100 and 120 mmHg perioperatively. Furthermore, HTN is also a risk factor for the rupture of unoperated type B AD. Despite this, only two studies have looked at BP management in AD patients. The first, carried out among chronic type A or B AD patients revealed that closer monitoring of blood pressure levels at home led to a better long-term prognosis. Another study revealed a 60% prevalence of non-managed clinical HTN among 40 chronic AD patients.
Whilst frequent, regular aortic wall monitoring via imaging methods (CT or MRI) is recommended after thoracic AD surgery, there is no precise recommendation as to the method of BP monitoring in very high-risk patients. A BP level of 135/80 mmHg has been suggested as a maximum limit for patients having been operated for AD. In order to achieve this, antihypertensives of several therapeutic classes must be used, with beta-blockers as a priority. The same can be said for AH, as it has been demonstrated that the absence of beta-blocker treatment is a predictive factor for poor progress.
Increased aortic stiffness can cause increased systolic blood pressure and is recognized as an independent cardiovascular risk factor. This stiffness can be detected by measuring the carotid-to-femoral pulse wave velocity (PWV). No study has as yet focused on assessing aortic stiffness in patients who have undergone AD or AH surgery.
Obstructive sleep apnea syndrome (OSAS) in thoracic AD patients is highly prevalent, and respiratory events that occur are more severe. This has prompted some to suggest that systematic detection of OSAS after AD should be carried out. No findings have yet been published about patients who have undergone AH surgery.
Read the detailed description
Main objective:
- To evaluate the level of blood pressure control using ambulatory blood pressure monitoring in patients who have undergone surgery for a type A thoracic AD or AH.
Secondary objectives:
- To study aortic stiffness within this patient population and determine its predictive parameters.
- To determine the prevalence of OSAS among this patient population and study the relationship between respiratory data and blood pressure values.
- To determine the respective roles of blood pressure level, aortic stiffness, and respiratory and biological parameters upon the postoperative aortic diameters of patients who have undergone surgery for type A thoracic AD or AH.
- Conditions
- Blood Pressure
- Being tested
- Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)
- Keywords
- aortic dissection, ambulatory blood pressure, obstructive sleep apnea syndrome, patients undergoing surgery for a dissection of the thoracic aorta
- Medical subject headings
- Aortic Dissection, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)Procedure or surgery
- Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)
- Blood pressure
- Obstructive sleep apnea syndrome (OSAS)
- Carotid-to-femoral pulse wave velocity (PWV)
- Biological parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitoring
Measured: the same day as inclusion
Secondary outcomes (2)
Aortic stiffness, Aortic diameters
Measured: the same day as inclusion
polysomnography to research Sleep apnea
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- jean-philippe baguet, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068691
- Sponsor's protocol ID
- 706
- Other IDs
- 2007-A01422-51
- Acronym
- ao_diss
- Status last verified
- Feb 2010
- First submitted
- 22 Jun 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Control and Arterial Properties After Surgical Treatment of Type A Thoracic Aortic Dissection or Haematoma
- ClinicalTrials.gov ID
- NCT01068691
- Acronym / sponsor ID
- ao_diss / 706
- Conditions
- Blood Pressure
- Keywords
- aortic dissection, ambulatory blood pressure, obstructive sleep apnea syndrome, patients undergoing surgery for a dissection of the thoracic aorta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 15 Feb 2010 (estimated)
- 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.
A dissecting or intramural haematoma of the thoracic aorta (AH) is a haemorrhage that dissects the aortic wall. An entry point is detected at an intimal tear, ulcer or plaque rupture via imaging in almost 50% of cases. AH occurs in older patients than those with AD and develops on atheromatous lesions with parietal ulcers, most often in cases of poorly managed, pre-existing hypertension (HTN). Type A AHs, which affect the ascending aorta, frequently progress towards an AD with a high risk of mortality, and represent a surgical indication.
Patients who have presented AD or AH, whether they have been operated or not, must undergo prolonged monitoring. This involves both clinical and radiological checks to ensure that blood pressure is properly monitored, that the parietal lesions have receded and that there are no complications.
HTN is a recognized risk factor for the onset of AD and systolic blood pressure must be brought down to between 100 and 120 mmHg perioperatively. Furthermore, HTN is also a risk factor for the rupture of unoperated type B AD. Despite this, only two studies have looked at BP management in AD patients. The first, carried out among chronic type A or B AD patients revealed that closer monitoring of blood pressure levels at home led to a better long-term prognosis. Another study revealed a 60% prevalence of non-managed clinical HTN among 40 chronic AD patients.
Whilst frequent, regular aortic wall monitoring via imaging methods (CT or MRI) is recommended after thoracic AD surgery, there is no precise recommendation as to the method of BP monitoring in very high-risk patients. A BP level of 135/80 mmHg has been suggested as a maximum limit for patients having been operated for AD. In order to achieve this, antihypertensives of several therapeutic classes must be used, with beta-blockers as a priority. The same can be said for AH, as it has been demonstrated that the absence of beta-blocker treatment is a predictive factor for poor progress.
Increased aortic stiffness can cause increased systolic blood pressure and is recognized as an independent cardiovascular risk factor. This stiffness can be detected by measuring the carotid-to-femoral pulse wave velocity (PWV). No study has as yet focused on assessing aortic stiffness in patients who have undergone AD or AH surgery.
Obstructive sleep apnea syndrome (OSAS) in thoracic AD patients is highly prevalent, and respiratory events that occur are more severe. This has prompted some to suggest that systematic detection of OSAS after AD should be carried out. No findings have yet been published about patients who have undergone AH surgery.
Detailed description
Main objective:
- To evaluate the level of blood pressure control using ambulatory blood pressure monitoring in patients who have undergone surgery for a type A thoracic AD or AH.
Secondary objectives:
- To study aortic stiffness within this patient population and determine its predictive parameters.
- To determine the prevalence of OSAS among this patient population and study the relationship between respiratory data and blood pressure values.
- To determine the respective roles of blood pressure level, aortic stiffness, and respiratory and biological parameters upon the postoperative aortic diameters of patients who have undergone surgery for type A thoracic AD or AH.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a pilot, descriptive and single-centre study.
Key inclusion criteria (6 listed)
- benefit from the French social security system
- will be monitored as outpatients
- have given their written consent to participate in this study
- have been operated over 6 months ago for a type A thoracic AD or AH at Grenoble University Hospital in the period from 1 January 1990 to 30 June 2007
- are able to travel to Grenoble University Hospital
Key exclusion criteria (10 listed)
- Bedridden or reduced mobility patients.
- Patients whose physical or psychological condition could affect their informed consent and compliance with the requirements of the protocol.
- Adult patients protected by the law (article L1121-8 of the French Public Health Code).
- Individuals serving a prison sentence (article L1121-8 of the French Public Health Code).
- Women who are pregnant, have recently given birth or are breastfeeding.
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 |
|---|---|---|
| Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)* Ambulatory blood pressure monitoring (to evaluate the level of blood pressure) * Blood pressure * Obstructive sleep apnea syndrome (OSAS) * Carotid-to-femoral pulse wave velocity (PWV) * Biological parameters | Procedure or surgery | – |
Primary outcome
Ambulatory blood pressure monitoring
Time frame: the same day as inclusion
2 secondary outcomes
Aortic stiffness, Aortic diameters
Time frame: the same day as inclusion
polysomnography to research Sleep apnea
Time frame: within 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
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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.
jean-philippe baguet, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 10 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 BAGUET Jean-Philippe, MD, PhD ((33+) 476768480, JPBaguet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure monitoring (time frame: the same day as inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2010.