deltatrials
Unknown OBSERVATIONAL NCT01160159

Arterial Microcirculation, Macrocirculation and Thrombophilias (MICMAC)

Sponsor: Assistance Publique - Hôpitaux de Paris

Conditions Thrombophilia
Updated 7 times since 2017 Last updated: Jul 9, 2010 Started: Mar 31, 2010 Primary completion: Mar 31, 2012 Completion: Mar 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01160159, this observational or N/A phase trial focuses on Thrombophilia and remains ongoing. Sponsored by Assistance Publique - Hôpitaux de Paris, it has been updated 7 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotUnknown Status~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Unknown Status

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Unknown Status NA

    First recorded

Mar 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Assistance Publique - Hôpitaux de Paris
Data source: Assistance Publique - Hôpitaux de Paris

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations