Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

Diastolic Dysfunction Clinical Trial

Official title:

Analysis of Incidence and Risk Factors of Severe Cardiovascular Events in Patients With Diastolic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138109
• Other study ID #: MACEDD
• Status: Completed
• Start date: August 31, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2018
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The investigators retrospected patients underwent noncardiac surgery with pre-operative echocardiography and was diagnosed with diastolic dysfunction in 2015 in Peking University First Hospital. Patients' perioperative data were collected. Major adverse cardiovascular events(MACE), other complication incidence, and post-operative hospital stay were reviewed. propotional harzad ratio cox survival model was established. Risk and protective factors relative to MACE were analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4347
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diastolic Dysfunction

Locations

Country	Name	City	State
China	First hospital Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yan Zhou, MD

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

Fischer M, Baessler A, Hense HW, Hengstenberg C, Muscholl M, Holmer S, Döring 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	major cardiac complications	30 days