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

NCT01357499 | Withdrawn

• 1 other identifier: 1-reinthaler
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• ST deviation

  Immediately after the preconditioning cycle the PCI ballon will be positioned in the coronary artery lesion and inflated for 2 minutes followed by 5 minutes of reperfusion. This cycle will be repeated for 3 times without any interruption. Intracoronary ECGs and 12 lead surface ecgs will be taken immediately before and at the end of each ballon inflation (two minutes after beginning the intracoronary ballon inflation). after taking the ecgs the ballon will be deflated. The st-deviations will be analysed.

  120 seconds after angioplasty

Secondary Outcomes (2)

• troponin I

  24 hours after PCI

• chest pain (Maximum)

  time period 2 minutes

Study Arms (3)

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.

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.

Device: blood pressure cuff

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

Device: blood pressure cuff + electric muscle stimulator

Interventions

blood pressure cuff 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 1

blood pressure cuff + electric muscle stimulator 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.

intervention group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Ernst Moritz Arndt Universität Greifswald

Greifswald, MVP, 17489, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples (10 ml) will be taken from the femoral vein of the preconditioned leg immediately before and after the preconditioning cycles. Also arterial blood samples (10 ml)will be taken immediately before and after the preconditioning cycle.

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Markus Reinthaler, MD

  Ernst Moritz Arndt University Greifswald

  PRINCIPAL INVESTIGATOR

• Thorsten Reffelmann, MD

  Ernst Moritz Arndt University Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 20, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

DE (1)