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

NCT ID: NCT01357499

Last Updated: 2016-11-16

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

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Heart Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg but without inflating the cuff and without stimulating the muscle. Now 25 minutes will have to pass by before beginning the coronary angioplasty.

No interventions assigned to this group

intervention group 1

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. There will be no electrical muscle stimulation in this group.

blood pressure cuff

Intervention Type DEVICE

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times.

intervention group 2

A Blood pressure cuff and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle

blood pressure cuff + electric muscle stimulator

Intervention Type DEVICE

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.

Interventions

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blood pressure cuff

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times.

Intervention Type DEVICE

blood pressure cuff + electric muscle stimulator

A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* planned PCI of one of the main coronary artery (artery diameter distal of the stenotic area at least 2,5 mm)
* patient age 18 years or older
* stable angina pectoris symptoms

Exclusion Criteria

* presence of collateral vessels
* electrocardiographic bundle branch blocks
* multiple coronary stenosis
* occlusion of a coronary artery
* renal insufficiency (GFR (MDRD) \< 50 ml/min/1,73 m2)
* presence of coronary bypass grafts
* history or presence of myocardial infarction.
* echocardiographic signs of left ventricular hypertrophy (septal and/or posterior wall diameter greater than 14 mm)
* some sort of medications (adenosine, morphine and derivates, immunosuppressive agents, oral antibiotics, theophyllin, alpha receptor blockers)
* peripheral arterial disease
* exercise tests performed within 24 h before study start.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Marcus Doerr

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Reinthaler, MD

Role: PRINCIPAL_INVESTIGATOR

Ernst Moritz Arndt University Greifswald

Thorsten Reffelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Ernst Moritz Arndt University Greifswald

Locations

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Ernst Moritz Arndt Universität Greifswald

Greifswald, MVP, Germany

Site Status

Countries

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Germany

Other Identifiers

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1-reinthaler

Identifier Type: -

Identifier Source: org_study_id