MedDataX Logo

Remote Ischemic Preconditioning for Renal Protection in TAVI

NCT ID: NCT03347032

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-13

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis Renal Insufficiency Contrast-induced Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type PROCEDURE

Serial inflations and deflations as detailed in the arm/group descriptions

Control

This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Serial inflations and deflations as detailed in the arm/group descriptions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote ischemic preconditioning

Serial inflations and deflations as detailed in the arm/group descriptions

Intervention Type PROCEDURE

Control

Serial inflations and deflations as detailed in the arm/group descriptions

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention

Exclusion Criteria

* Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
* Systemic hypotension (systolic blood pressure \< 90mmHg)
* Patients currently on hemodialysis
* Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
* Patients enrolled in other active cardiovascular investigational studies
* Severe comorbidities with a life expectancy of less than 6 months
* Pregnant or lactating women
* Patients unable to provide consent
* Patients taking the medication glibenclamide for treatment of diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brittany Fuller, MD

Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William O'Neill, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RIPC TAVI

Identifier Type: -

Identifier Source: org_study_id