Ischemic Heart DiseaseREMOTENCT01357499
Lower Leg Remote Ischemic Preconditioning in Elective Percutaneous Coronary Intervention (PCI)
An observational study of Ischemic Heart Disease, run by University Medicine Greifswald at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- blood pressure cuff and blood pressure cuff + electric muscle stimulator
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ernst Moritz Arndt Universität Greifswald
Greifswald, MVP, 17489
About this study
Official title: Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
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.
Read the detailed 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- blood pressure cuff, blood pressure cuff + electric muscle stimulator
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure cuffDevice
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 stimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: blood pressure cuff + electric muscle stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 seconds after angioplasty
Secondary outcomes (2)
troponin I
Troponin levels will be evaluated 24 h after PCI
Measured: 24 hours after PCI
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.
Measured: time period 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: PI left center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Doerr, University Medicine Greifswald
- Investigators
- Markus Reinthaler, MD, Principal investigator, Ernst Moritz Arndt University GreifswaldThorsten Reffelmann, MD, Principal investigator, Ernst Moritz Arndt University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357499
- Sponsor's protocol ID
- 1-reinthaler
- Acronym
- REMOTE
- Status last verified
- Nov 2016
- First submitted
- 10 May 2011
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Leg Remote Ischemic Preconditioning in Combination With Electric Muscle Stimulation in Elective Coronary Artery Revascularisation
- ClinicalTrials.gov ID
- NCT01357499
- Acronym / sponsor ID
- REMOTE / 1-reinthaler
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: blood pressure cuffA 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. |
| intervention group 2 | – | Device: blood pressure cuff + electric muscle stimulatorA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective PCI fulfilling the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure cuffA 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. | Device | intervention group 1 |
| blood pressure cuff + electric muscle stimulatorA 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. | Device | intervention group 2 |
Primary outcome
ST deviation
Time frame: 120 seconds after angioplasty
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.
2 secondary outcomes
troponin I
Time frame: 24 hours after PCI
chest pain (Maximum)
Time frame: time period 2 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Reinthaler, MD principal investigator
Ernst Moritz Arndt University Greifswald
Thorsten Reffelmann, MD principal investigator
Ernst Moritz Arndt University Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ST deviation (time frame: 120 seconds after angioplasty). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.