NCT03424785

Brief Summary

The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 7, 2018

Status Verified

December 1, 2017

Enrollment Period

9 years

First QC Date

December 11, 2017

Last Update Submit

February 6, 2018

Conditions

Aortic Intramural Hematoma

Keywords

Aortic intramural hematomaChinese patientsClinical outcomes

Outcome Measures

Primary Outcomes (1)

  • hematoma thickness and a baseline MAD

    Medication and short-term imaging are recommended for Chinese IMH patients with a hematoma thickness less than 10.45 mm and a baseline MAD less than 44.75 mm. Rigorous medical observation should also be performed during the acute phase of IMH.

    14years

Interventions

drug, stent, surgical treatmentOTHER

drug, stent, surgical treatment

Eligibility Criteria

Age30 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123 patients were retrospectively examined. Thirty-nine patients presented with type A aortic IMH, and 84 presented with type B aortic IMH

You may qualify if:

  • Type A aortic hematoma
  • Type B aortic hematoma

You may not qualify if:

  • Aortic without initial intimal flap formation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Harris KM, Braverman AC, Eagle KA, Woznicki EM, Pyeritz RE, Myrmel T, Peterson MD, Voehringer M, Fattori R, Januzzi JL, Gilon D, Montgomery DG, Nienaber CA, Trimarchi S, Isselbacher EM, Evangelista A. Acute aortic intramural hematoma: an analysis from the International Registry of Acute Aortic Dissection. Circulation. 2012 Sep 11;126(11 Suppl 1):S91-6. doi: 10.1161/CIRCULATIONAHA.111.084541.

    PMID: 22965999RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Imaging Samples

MeSH Terms

Conditions

Aortic Intramural Hematoma

Interventions

Pharmaceutical PreparationsStentsSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Acute Aortic SyndromeAortic DiseasesVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Long term follow-up and clinical implications in Chinese patients with aortic intramural hematoma

Study Record Dates

First Submitted

December 11, 2017

First Posted

February 7, 2018

Study Start

June 3, 2008

Primary Completion

May 14, 2017

Study Completion

May 14, 2017

Last Updated

February 7, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share