Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to investigate if remote ischemic preconditioning by combining limb ischaemia with electric muscle stimulation of the ischemic muscle provokes better results in preconditioning the human heart than limb ischaemia alone does.

Clinical Trial Description

It has been demonstrated that protection from ischemia reperfusion can be achieved by brief periods of ischemia applied at a remote site during an injurious ischemic event (remote postconditioning). The purpose of this study is to investigate if the combination of brief periods of limb ischemia in combination with electric muscle stimulation at the same site could exceed the preconditioning effect of limb ischemia alone.

Therefore the investigators thought to perform 2 different forms of remote ischaemic preconditioning in patients undergoing elective coronary angioplasty.

In the first patient group a blood pressure cuff will be applied at the lower leg. Ischemia will be induced by inflating the cuff to a pressure of 200 mmHg for 5 minutes. Afterwards reperfusion will be allowed for further 5 minutes. This cycle will be repeated 3 times.

In a second patient group electric muscle stimulation at the same site (HiToP 191) will be performed additionally throughout the whole preconditioning cycle.

After preconditioning, the percutaneous coronary intervention (PCI) will be performed by 3 PCI-ballon inflations, each lasting for 2 minutes. Between the inflations coronary reperfusion will be allowed for 5 minutes.

The Effects of preconditioning will be evaluated by analysing the ST-deviation, caused by angioplasty in an intracoronary (derived by PCI wire) and surface ecg.

Also the maximum of chest pain during the 3 inflation cycles and troponin levels 24 h after PCI will be evaluated. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01357499
Study type	Observational
Source	University Medicine Greifswald
Contact
Status	Withdrawn
Phase	Phase 0
Start date	December 2010
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Active, not recruiting	`NCT04562805` - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)	N/A
Recruiting	`NCT05292079` - CAPTURER PMCF Study ( rEPIC04D )
Recruiting	`NCT05292014` - ANGIOLITE PMCF Study ( rEPIC04F )
Recruiting	`NCT05292092` - Essential Pro PMCF Study ( rEPIC04E )
Recruiting	`NCT05292118` - Navitian PMCF Study ( rEPIC04C )
Completed	`NCT05292105` - NC Xperience PMCF Study( rEPIC04B)
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Not yet recruiting	`NCT04153383` - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Recruiting	`NCT02982434` - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation	Phase 2
Completed	`NCT02468401` - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions	N/A
Completed	`NCT02759406` - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study	N/A
Recruiting	`NCT01681381` - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization	N/A
Completed	`NCT01604213` - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease	Phase 4
Completed	`NCT01699802` - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)	N/A
Completed	`NCT01724567` - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training	N/A
Completed	`NCT01334268` - RESOLUTE China RCT	N/A
Completed	`NCT02159235` - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI) — REMOTE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms