NCT02236923

Brief Summary

That the full-moon stage of the lunar cycle is associated with reduced mortality and shorter length of stay in patients undergoing repair of aortic dissection, after adjusting for seasonal effects, demographics and cardiovascular risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 1998

Completed
15.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

15.9 years

First QC Date

September 8, 2014

Last Update Submit

September 9, 2014

Conditions

Aneurysm, DissectingAortic Aneurysm

Keywords

cardiovascularsurgeryascending aortaaortic dissection

Outcome Measures

Primary Outcomes (2)

  • All cause in-hospital mortality

    During hospital stay, an expected average of 8 days

  • Length of stay in hospital among survivors to discharge

    During hospital stay, an expected average of 18 days

Study Arms (2)

Group A: Single procedure

Group A consists of patients recorded as having only had an ascending aortic dissection repair procedure.

Group B: Multiple procedures

Group B consists of patients who had an ascending aortic dissection repair procedure together with any other surgical intervention.

Eligibility Criteria

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

All acute ascending aortic dissection repair procedures recorded in the United Kingdom's National Adult Cardiac Surgery Audit.

You may qualify if:

  • acute dissection specified in aortic pathology

You may not qualify if:

  • missing data in the demographic covariates (age, sex)
  • missing data in the medical history (hypertension, diabetes, renal failure)
  • missing surgical procedure date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Cardiovascular Outcomes Research

London, W1T 7HA, United Kingdom

Location

Related Publications (1)

  • Shuhaiber JH, Fava JL, Shin T, Dobrilovic N, Ehsan A, Bert A, Sellke F. The influence of seasons and lunar cycle on hospital outcomes following ascending aortic dissection repair. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):818-22. doi: 10.1093/icvts/ivt299. Epub 2013 Jul 9.

    PMID: 23838340BACKGROUND

MeSH Terms

Conditions

Aortic DissectionAortic Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Officials

  • Emmanuel Lazaridis, PhD, LLB

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 11, 2014

Study Start

January 1, 1998

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

GB(1)