NCT06397092

Brief Summary

To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

April 7, 2024

Last Update Submit

May 1, 2024

Conditions

Outcome Measures

Primary Outcomes (10)

  • Perioperative information 1

    Heart reat

    During surgery, when use isoproterenol to provocate

  • Perioperative information 2

    Systolic arterial blood pressure

    During surgery, when use isoproterenol to provocate

  • Perioperative information 3

    Diastolic arterial blood pressure

    During surgery, when use isoproterenol to provocate

  • Perioperative information 4

    Mean arterial blood pressure

    During surgery, when use isoproterenol to provocate

  • Perioperative information 5

    The type of tracheal tube

    Immediately after the surgery

  • Perioperative information 6

    The usage of anaesthetic drugs

    Immediately after the surgery

  • Perioperative information 7

    The usage of cardiovascular drugs

    Immediately after the surgery

  • Perioperative information 8

    Intraoperative infusion volume

    Immediately after the surgery

  • Perioperative information 9

    Blood transfusion volume

    Immediately after the surgery

  • Perioperative information 10

    Blood loss

    Immediately after the surgery

Secondary Outcomes (8)

  • Postoperative information 1

    Postoperative in 30 days

  • Postoperative information 2

    Postoperative in 30 days

  • Postoperative information 3

    Postoperative in 30 days

  • Postoperative information 4

    Postoperative in 30 days

  • Laboratory tests information 1

    7 days before surgery and 3 days after surgery

  • +3 more secondary outcomes

Study Arms (1)

TA-BSM

The hypertrophic cardiomyopathy patients received TA-BSM

Procedure: transapical beating-heart septal myectomy

Interventions

The patients with hypertrophic cardiomyopathy undergoing TA-BSM

TA-BSM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2022 to January 2023 was extracted and screened according to the inclusion criteria and exclusion criteria

You may qualify if:

  • Patients with hypertrophic cardiomyopathy
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Undergoing TA-BSM

You may not qualify if:

  • Cardiopulmonary bypass was used to assist the surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Wenlong Yao

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and deputy chief physician

Study Record Dates

First Submitted

April 7, 2024

First Posted

May 2, 2024

Study Start

April 1, 2022

Primary Completion

January 31, 2023

Study Completion

March 31, 2024

Last Updated

May 2, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations