NCT02551328

Brief Summary

The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \\propofol)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

9 months

First QC Date

September 1, 2015

Last Update Submit

September 15, 2015

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • Myocardial Injury assessed by changes in Troponin values

    According to the routine post operative blood testing frame-time troponin sample will collected in the preoperative and postoperative period.

    properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest

Study Arms (2)

Sevofluorane

Patients preconditioned with Sevo

Drug: sevofluorane

Propofol

Patients with no preconditioning

Interventions

sevofluoraneDRUG

Continuous infusion of sevofluorane

Also known as: SEVO
Sevofluorane

Eligibility Criteria

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

Age\>=18 Pt undergoing elective (or urgent) first-time minimal invasive mitral valve surgery Pt will have to sign informed consent

You may qualify if:

  • Age ≥18
  • Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.

You may not qualify if:

  • Cardiogenic shock or cardiac arrest, emergent CABG
  • Renal failure (with a GFR \< 30 ml/min/1.73m2),
  • Glibenclamide or nicorandil (as these medications may interfere with VC)
  • Pregnancy
  • Known intolerance/allergy to sevoflurane or propofol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio

Massa, Italy, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Paolo Del Sarto, MD

    Fondazione Toscana Gabriele Monasterio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Parlanti, Pharmacist

CONTACT

0039/0585/493675/493565alessandra.parlanti@ftgm.it-parlantialessandra@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 16, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations

IT(1)