NCT03138109

Brief Summary

This retrospective cohort study was intended to analyze the incidence and risk factors of perioperative severe cardiovascular events in patients with diastolic dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

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

August 31, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

April 30, 2017

Last Update Submit

September 12, 2018

Conditions

Diastolic Dysfunction

Keywords

non-cardiac surgerymajor adverse cardiac event

Outcome Measures

Primary Outcomes (1)

  • MACE

    major cardiac complications

    30 days

Study Arms (2)

grade1&2 diastolic dysfunction

lower diastolic dysfunction exposure

grade 3 diastolic dysfunction

higher diastolic dysfunction exposure

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with diastolic dysfunction

You may qualify if:

  • years old or older, with echocardiographic diagnosis of left ventricular diastolic dysfunction (while ejection fraction was \> = 50%) conducted by cardiologist within 90 days before surgery.

You may not qualify if:

  • congenital heart disease, moderate to severe valvular disease (stenosis or insufficiency), atrial fibrillation / atrial flutter, pericarditis, unsatisfied cardiac ultrasound image, ejection fraction \< 50%, ASA greater than 4, or Echocardiography is missing or incomplete.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital Peking University

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (6)

  • Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA, Waggoner AD, Flachskampf FA, Pellikka PA, Evangelisa A. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009 Mar;10(2):165-93. doi: 10.1093/ejechocard/jep007. No abstract available.

    PMID: 19270053BACKGROUND

  • Fischer M, Baessler A, Hense HW, Hengstenberg C, Muscholl M, Holmer S, Doring A, Broeckel U, Riegger G, Schunkert H. Prevalence of left ventricular diastolic dysfunction in the community. Results from a Doppler echocardiographic-based survey of a population sample. Eur Heart J. 2003 Feb;24(4):320-8. doi: 10.1016/s0195-668x(02)00428-1.

    PMID: 12581679BACKGROUND

  • Roongsritong C, Qaddour A, Cox SL, Labib S, Bradley CA. Brain natriuretic peptide and diastolic dysfunction in the elderly: influence of gender. Congest Heart Fail. 2005 Mar-Apr;11(2):65-7. doi: 10.1111/j.1527-5299.2005.03747.x.

    PMID: 15860970BACKGROUND

  • Redfield MM, Jacobsen SJ, Burnett JC Jr, Mahoney DW, Bailey KR, Rodeheffer RJ. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA. 2003 Jan 8;289(2):194-202. doi: 10.1001/jama.289.2.194.

    PMID: 12517230BACKGROUND

  • Fayad A, Ansari MT, Yang H, Ruddy T, Wells GA. Perioperative Diastolic Dysfunction in Patients Undergoing Noncardiac Surgery Is an Independent Risk Factor for Cardiovascular Events: A Systematic Review and Meta-analysis. Anesthesiology. 2016 Jul;125(1):72-91. doi: 10.1097/ALN.0000000000001132.

    PMID: 27077638BACKGROUND

  • Devereaux PJ, Goldman L, Yusuf S, Gilbert K, Leslie K, Guyatt GH. Surveillance and prevention of major perioperative ischemic cardiac events in patients undergoing noncardiac surgery: a review. CMAJ. 2005 Sep 27;173(7):779-88. doi: 10.1503/cmaj.050316.

    PMID: 16186585BACKGROUND

Study Officials

  • Yan Zhou, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

April 30, 2017

First Posted

May 3, 2017

Study Start

August 31, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)