The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT06079008

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about the association between cardiac valve calcification and the 1-year mortality after lower-extremity amputation in diabetic patients. Diabetic patients requiring lower-extremity amputation were retrospectively studied. Preoperative detailed anamnesis was taken. Cardiac valve calcification was assessed using echocardiography at baseline. One-year follow-up was conducted and included clinical visits, hospital record assessment, and telephone reviews to obtain the survival status of patients. Researchers compare the survival group to the mortality group to study the relationship between the cardiac valve calcification and mortality.

Condition or Disease	Intervention/Treatment	Phase
Amputation Diabetic Foot Valve Disease, Aortic Valve Heart Disease	Other: calcified cardiac valve

Detailed Description

This study aimed to investigate the association between cardiac valve calcification and 1-year mortality in diabetic patients after lower-extremity amputation. The investigator recruited consecutive patients who were admitted to the Sun Yat-sen Memorial Hospital for diabetic foot ulcers that needed amputation surgery. Clinical characteristics of each patient and the laboratory examination were collected before surgery. Cardiac valve calcification was assessed at baseline. This study obtained the survival status of patients within one year through outpatient follow-up and telephone follow-up. Researchers compared the survival group to the mortality group to see if the mortality group had a higher prevalence of heart valve calcification.

Study Design

Study Type:

Observational

Actual Enrollment :

96 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients: a Retrospective Study

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
survival group The patients who survived more than 1-year after amputation surgery.	Other: calcified cardiac valve patients have cardiac cardiac valve before surgery
mortality group The patients who were dead within 1-year after amputation surgery.	Other: calcified cardiac valve patients have cardiac cardiac valve before surgery

Arm

Intervention/Treatment

survival group

The patients who survived more than 1-year after amputation surgery.

Other: calcified cardiac valve

patients have cardiac cardiac valve before surgery

mortality group

The patients who were dead within 1-year after amputation surgery.

Other: calcified cardiac valve

patients have cardiac cardiac valve before surgery

Outcome Measures

Primary Outcome Measures

The proportion of cardiac valve calcification between survival group and mortality group [2017-12-1]
The prevalence of calcified heart valve diseases was compared between the mortality group and survival group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Had echocardiography at baseline
With diabetic foot ulcers that required amputation after orthopedist's assessment

Exclusion Criteria:

Fractures due to traumatic reasons that required extremity amputation
Amputation level below the ankle
Severe sepsis that required vasoactive agent treatment
Rheumatic heart disease
Heart valve surgery history

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT06079008

Other Study ID Numbers:

SYSKY-2022-035-01

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2023