Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01357499
Other study ID # 1-reinthaler
Secondary ID
Status Withdrawn
Phase Phase 0
First received May 10, 2011
Last updated November 15, 2016
Start date December 2010
Est. completion date December 2013

Study information

Verified date November 2016
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Device:
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.
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.

Locations

Country Name City State
Germany Ernst Moritz Arndt Universität Greifswald Greifswald MVP

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary troponin I Troponin levels will be evaluated 24 h after PCI 24 hours after PCI No
Secondary chest pain (Maximum) the maximal chest pain occuring during each of the Pci balloon inflations will be documented as a number out of 10. 0 is determined as no pain and 10 is determined as the heaviest pain which the patient ever experienced. A specific timepoint has not been defined. time period 2 minutes No
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