ThrombophiliaMICMACNCT01160159
Arterial Microcirculation, Macrocirculation and Thrombophilias
An observational study of Thrombophilia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Rationale: To analyse the arterial state of women with thrombophilia by techniques studying micro and arterial macrocirculation because of a reported and still discussed increase risk in cardio-vascular events in these women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thrombophilia
- What is being tested?
- Tests and Healthy volunteers
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2010to 16 Apr 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.
Who may be able to join
- healthy volunteers
- 18-45 years old women of child bearing age
- Without any hormonal contraception nor any hormone treatment since at least 3 months
- Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking> 5 cigaret )
- Patient who have signed an inform consent
- With no thrombophilia : normal sample for factor V and II mutations
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- Willing to participate to the study
- Adherent to health insurance
- Previous Clinical examination
- women with thrombophilia
- 18-45 years old women of child bearing age
- Without any hormonal contraception nor any hormone treatment since at least 3 months
- Without any arterial risk factors (HTA, diabetes, dyslipemia, obesity, including smoking> 5 cigaret )
- Patient who have signed an inform consent
- With thrombophilia : normal sample for factor V and II mutations
- Willing to participate to the study
- Adherent to health insurance
- Previous Clinical examination
Who cannot join
- Women under hormonal contraception or who have stopped it less than 3 months ago
- Women under anticoagulant
- Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI>30), including smoking> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE
- History of coronaropathy or of stroke
- Pregnant women or willing to conceive
- Severe liver disease
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- Women of less than 18y or older than 45y
- Severe liver diseases
- Patient not willing to sign up the inform consent
- Patient refusal to participate
- Endometrial cancer
- Unexplored bleeding
- Women not willing to participate or included in another trial
- Woman with another thrombophilic disorder (ATIII, protein C, S, history of VTE without any biological thrombophilic disorder.
- Women with at least one of the following treatment and who cannot stop it 48h before the arterial investigations.
- Gynergen caffeine
- NOCERTONE® oxetorone
- SIBÉLIUM®flunarizine
- VIDORA®indoramine
- SANMIGRAN® 0,50 mg pizotifen
- woman under propranolol AVLOCARDYL® 40 mg *AVLOCARDYL® LP 160 mg
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Hotel Dieu - Consultation Gynécologie et d'Hémostase
Paris, 75004
About this study
Rationale: To analyse the arterial state of women with thrombophilia by techniques studying micro and arterial macrocirculation because of a reported and still discussed increase risk in cardio-vascular events in these women.
Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in women with thrombophilia.
Read the detailed description
There are several papers reporting an increase in the risk of arterial diseases in women with thrombophilia. However these reports remain controversial. In order to gain insight on that issue we propose to study the micro and macrocirculation in women with an history of venous thrombosis or thrombophilia and in controls matched by age.
Design: It is a prospective open transversal trial.
Management of the study: Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia. Following an inclusion consultation where the informed consent will be obtained and inclusion criteria checked, an appointment for the arterial explorations will be given. These explorations will be measurement of endothelium dependent vasodilatation (EDV), capillar density, arterial fitness and compliance and retinogram. There is no follow-up visit.Benefits and risks: the measurement will characterize the arterial state of patients with thrombophilia included in the study.There is no risk in performing these techniques.
Principal criteria: measurement of EDV.
Secondary criteria: capillar density, arterial compliance and stiffness and retinogram.
- Conditions
- Thrombophilia
- Being tested
- Tests, Healthy volunteers
- Keywords
- Venous thrombosis, Women, Vasodilatation endothelium-dependent, IMT, Arterial stiffness, Arterial compliance, Capillary density
- Medical subject headings
- Thrombophilia, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestsOther
Arterial parameters
Healthy volunteersOther
Arterial parameters and blood test
| Study group | Role | What they receive |
|---|---|---|
| Thrombophilia | Not described Receives: Other: Tests | |
| Healthy volunteers | Not described Receives: Other: Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasodilatation endothelium-dependent (VDE)
Measured: at 2 months max after inclusion
Secondary outcomes (3)
Capillary density
Measured: at 2 months max after inclusion
Stiffness and arterial compliance
Measured: at 2 months max after inclusion
Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software
Measured: at 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start16 Mar 2010
- Primary completion16 Apr 2010
- Study completion16 Apr 2010
Why it stopped: COORDINATING INVESTIGATOR'S DECISION
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombophiliaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GOMPEL, MD-PhD, Study chair, Assistance Publique - Hôpitaux de ParisGeneviève PLU-BUREAU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160159
- Sponsor's protocol ID
- P071012
- Other IDs
- IDRCB 2008-A01635-50
- Acronym
- MICMAC
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2010
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Microcirculation, Macrocirculation and Thrombophilias
- ClinicalTrials.gov ID
- NCT01160159
- Acronym / sponsor ID
- MICMAC / P071012
- Conditions
- Thrombophilia
- Keywords
- Venous thrombosis, Women, Vasodilatation endothelium-dependent, IMT, Arterial stiffness, Arterial compliance, Capillary density
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COORDINATING INVESTIGATOR'S DECISION
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Mar 2010 (actual)
- Primary completion
- 16 Apr 2010 (actual)
- Study completion
- 16 Apr 2010 (actual)
- First posted
- 12 Jul 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.
Rationale: To analyse the arterial state of women with thrombophilia by techniques studying micro and arterial macrocirculation because of a reported and still discussed increase risk in cardio-vascular events in these women.
Primary objective: To measure endothelium dependent vasodilatation (VDE) in controls and in women with thrombophilia.
Detailed description
There are several papers reporting an increase in the risk of arterial diseases in women with thrombophilia. However these reports remain controversial. In order to gain insight on that issue we propose to study the micro and macrocirculation in women with an history of venous thrombosis or thrombophilia and in controls matched by age.
Design: It is a prospective open transversal trial.
Management of the study: Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia. Following an inclusion consultation where the informed consent will be obtained and inclusion criteria checked, an appointment for the arterial explorations will be given. These explorations will be measurement of endothelium dependent vasodilatation (EDV), capillar density, arterial fitness and compliance and retinogram. There is no follow-up visit.Benefits and risks: the measurement will characterize the arterial state of patients with thrombophilia included in the study.There is no risk in performing these techniques.
Principal criteria: measurement of EDV.
Secondary criteria: capillar density, arterial compliance and stiffness and retinogram.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombophilia | – | Other: Tests |
| Healthy volunteers | – | Other: Healthy volunteers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups of 80 women will be compared: healthy volunteers and women with thrombophilia.
Key inclusion criteria (18 listed)
- healthy volunteers
- women with thrombophilia
Key exclusion criteria (21 listed)
- Women under hormonal contraception or who have stopped it less than 3 months ago
- Women under anticoagulant
- Arterial risk factor : HTA, diabetes, dyslipemia, obesity(BMI>30), including smoking> 5 cigarets ), metabolic syndrome, antiphospholipids/anticoagulant antibody, SLE
- History of coronaropathy or of stroke
- Pregnant women or willing to conceive
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 |
|---|---|---|
| TestsArterial parameters | Other | Thrombophilia |
| Healthy volunteersArterial parameters and blood test | Other | Healthy volunteers |
Primary outcome
Vasodilatation endothelium-dependent (VDE)
Time frame: at 2 months max after inclusion
3 secondary outcomes
Capillary density
Time frame: at 2 months max after inclusion
Stiffness and arterial compliance
Time frame: at 2 months max after inclusion
Analysis of venous and arterial microcirculation using images acquired by retinogram and a specific software
Time frame: at 2 month
Results and safety
The study was stopped early (reason given: COORDINATING INVESTIGATOR'S DECISION). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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.
Anne GOMPEL, MD-PhD study chair
Assistance Publique - Hôpitaux de Paris
Geneviève PLU-BUREAU, MD, PhD 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?
An observational study of Thrombophilia, 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 18 inclusion and 21 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: stopped early, as of the sponsor's last update on 6 Apr 2026. 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?
The study was stopped early (reason given: COORDINATING INVESTIGATOR'S DECISION). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasodilatation endothelium-dependent (VDE) (time frame: at 2 months max after 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 6 Apr 2026.