NCT03354767

Brief Summary

Single-centre observational study over one year investigating the mechanisms of muscle homeostasis in patients with acute skeletal muscle atrophy following major aortic surgery

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

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

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

November 28, 2017

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

November 11, 2016

Last Update Submit

November 20, 2017

Conditions

Muscular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in Rectus Femoris muscle cross-sectional area (%)

    Percentage change in cross sectional area of Rectus Femoris muscle (cm2) in the first post-operative week, from pre-operative measurement (measured the day before surgery), repeated on day 7 post-operatively

    7 days

Study Arms (2)

Wasting patients

Patients with \>10% loss of skeletal muscle one week after major aortic surgery

Procedure: Aortic and aortic valve surgery

Non-wasting patients

Patients with \<10% loss of skeletal muscle one week after major aortic surgery

Procedure: Aortic and aortic valve surgery

Interventions

Aortic and aortic valve surgeryPROCEDURE
Non-wasting patientsWasting patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing major aortic or aortic valve surgery requiring cardiopulmonary bypass and aortic cross-clamping

You may qualify if:

  • All adult (\>18) patients undergoing major aortic or aortic valve surgery

You may not qualify if:

  • Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Plasma 2. Serum 3. Whole blood 4. Skeletal muscle

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 28, 2017

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

August 1, 2015

Last Updated

November 28, 2017

Record last verified: 2013-04

Data Sharing

IPD Sharing
Will not share