Chronic Dissection of Thoracic Aorta (Disorder)Phase 2PAIDDANCT03832582
Annexin Imaging in Dissection of the Descending Aorta
A Phase 2 study testing Annexin in people with Chronic Dissection of Thoracic Aorta (Disorder), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Dissection of Thoracic Aorta (Disorder)
- What is being tested?
- Annexin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 31 Dec 2024
- Phase
- Phase 2
- 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
Who may be able to join
- patient whose age is ≥ 18 years old
- any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta
- dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection
- effective contraception for women of childbearing age
Who cannot join
- scheduled procedure for dissection of the descending aorta
- contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance <30 ml/min or creatinine >200 µmol/l; allergy to contrast media
- history of surgery or stent implantation in the descending thoracic aorta
- pregnant or breastfeeding women
- patient under guardianship or trusteeship
- non affiliation to social security or CMU (beneficiary or assignee)
- patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Cardiologie - Hôpital Bichat Claude Bernard
Paris, 75018
Olivier Milleron, MD, 00 33 1 40 25 68 16, olivier.milleron-ext@aphp.fr
About this study
Official title: Prognostic of Annexin Imaging in Dissection of the Descending Aorta
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.
Read the detailed description
To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.
- Being tested
- Annexin
- Keywords
- Aorta, Type B dissection, Descending aorta dissection, Annexin
- Medical subject headings
- Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnnexinDrug
Also called Annexin scintigraphy
All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
| Study group | Role | What they receive |
|---|---|---|
| Annexin | Experimental | All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) Receives: Drug: Annexin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.
Measured: 30 months
Secondary outcomes (10)
Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve. The cut-off point will be defined by the Youden index.
Measured: 30 months
Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
Measured: 30 months
Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
Measured: 30 months
Morphological characteristics of the wall thrombus
Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen.
Measured: 30 months
Determination of potential predictive clinical factors of aortic dilation rate
Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan)
Measured: 30 months
Determination of potential predictive SPECT factors of aortic dilation rate
Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio)
Measured: 30 months
Determination of potential predictive biological factors of aortic dilation rate
Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate
Measured: 30 months
Determination of potential predictive morphological factors of aortic dilation rate
Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis.
Measured: 30 months
Number of cardiovascular events
Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery.
Measured: 30 months
Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence
Tolerance of the annexin scintigraphy will be assessed using a questionnaire during a phone call at day 3 to ask the patients about side effects occurrence.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 May 2019 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Dissection of Thoracic Aorta (Disorder)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Milleron, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832582
- Sponsor's protocol ID
- P1700905J
- Acronym
- PAIDDA
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic of Annexin Imaging in Dissection of the Descending Aorta
- ClinicalTrials.gov ID
- NCT03832582
- Acronym / sponsor ID
- PAIDDA / P1700905J
- Keywords
- Aorta, Type B dissection, Descending aorta dissection, Annexin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2019 (actual)
- 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.
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.
Detailed description
To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annexin | Experimental | Drug: AnnexinAll patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient whose age is ≥ 18 years old
- any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta
- dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection
- effective contraception for women of childbearing age
Key exclusion criteria (7 listed)
- scheduled procedure for dissection of the descending aorta
- contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance <30 ml/min or creatinine >200 µmol/l; allergy to contrast media
- history of surgery or stent implantation in the descending thoracic aorta
- pregnant or breastfeeding women
- patient under guardianship or trusteeship
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 |
|---|---|---|
| AnnexinAlso: Annexin scintigraphyAll patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) | Drug | Annexin |
Primary outcome
Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
Time frame: 30 months
Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy.
10 secondary outcomes
Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
Time frame: 30 months
Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
Time frame: 30 months
Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
Time frame: 30 months
Morphological characteristics of the wall thrombus
Time frame: 30 months
Determination of potential predictive clinical factors of aortic dilation rate
Time frame: 30 months
Determination of potential predictive SPECT factors of aortic dilation rate
Time frame: 30 months
Determination of potential predictive biological factors of aortic dilation rate
Time frame: 30 months
Determination of potential predictive morphological factors of aortic dilation rate
Time frame: 30 months
Number of cardiovascular events
Time frame: 30 months
Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Dissection of Thoracic Aorta (Disorder)
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
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.
Olivier Milleron, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Annexin in people with Chronic Dissection of Thoracic Aorta (Disorder), run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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 11 Feb 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Olivier Milleron, MD (00 33 1 40 25 68 16, olivier.milleron-ext@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending (time frame: 30 months). 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 11 Feb 2019.