Percutaneous Coronary InterventionPCI-StrainNCT02004483
Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI
A study testing Percutaneous Coronary Intervention in people with Percutaneous Coronary Intervention and Myocardial Ischemia, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Investigators will analyzed systolic and diastolic function during and after ischemia induced by percutaneous coronary intervention.Also will be analyzed a local work index during acute ischemia induced by percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Myocardial Ischemia, Anginal Pain
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Dec 2014
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Adequate quality of echocardiographic images.
- Significant stenosis of the proximal left anterior descending artery, the right coronary artery or the left circumflex artery
- Anginal pain or proven myocardial ischemia due to the coronary stenosis
- Elective percutaneous coronary intervention planned
- Planned direct stenting of the coronary artery
Who cannot join
- Prior myocardial infarction
- Significant coronary collaterals
- Significant valvular regurgitation (>Sellers II)
- Congestive heart failure
- Pacemaker dependency
- Bundle branch block or significant arrhythmia
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- Atrial fibrillation
- Previous coronary bypass grafting
- Impaired kidney function corresponding to a GFR(Glomerular filtration rate) below 60 mL/min.
- Women, who are pregnant or breastfeeding.
- Patient taking part in another clinical study
- Subjects who are committed to an institution and/or penitentiary by judicial or official order.
- Complex coronary lesion requiring balloon angioplasty or rotational atherectomy prior to stenting
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Investigators will analyzed systolic and diastolic function during and after ischemia induced by percutaneous coronary intervention.Also will be analyzed a local work index during acute ischemia induced by percutaneous coronary intervention.
Read the detailed description
PART 1: ANALYSIS OF LAYER SPECIFIC SYSTOLIC AND DIASTOLIC FUNCTION DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION 35 patients with normal systolic left ventricular function at baseline with indication for elective percutaneous coronary angioplasty will be included in the study. In these patients acute ischemia will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec. During these 60 seconds ischemia will develop throughout all layers of the myocardium affecting diastolic systolic and diastolic function. During the subsequent reperfusion period signs of ischemia with systolic and diastolic dysfunction of all layers will subside. Echocardiographic imaging at short intervals of 10 sec during ischemia and at intervals of 20 sec during reperfusion up to 10 min after reopening of the vessel as well as 1 hour and 24 hours later will allow serial comparison of strain curves and thereby allow definition of the time sequence systolic and diastolic function abnormalities occur in three myocardial layers as well as the resolution of abnormalities during reperfusion. The analysis of circumferential as well as radial strain will allow definition of differences between radial and circumferential strain during ischemia induction and resolution.
PART 2: ANALYSIS OF LOCAL WORK INDEX DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION.
In the same 35 patients as in Clinical step 1 the local work index of the ischemic area as well as the contralateral non-ischemic areas will be determined in serial studies to determine the onset of abnormality, the amount of abnormality and the resolution of abnormality. Changes in local work index in the ischemic area will be related to changes in peak systolic strain and strain imaging diastolic index.
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- percutaneous coronary intervention, ischemia, strain, coronary stenosis
- Medical subject headings
- Myocardial Ischemia, Angina Pectoris, Ischemia, Sprains and Strains, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous coronary intervention is performed according to standard practice. Direct stenting is required for the procedure as it is done in most coronary interventions today. After insertion of the non-inflated stent into the coronary lesion there should still be flow to the distal vessel. The stent should be implanted at high-pressure with balloon inflation lasting for 60 seconds to allow adequate expansion of the stent. Post-dilatation should be performed if required. However, this should be done more than 5 minutes after stent implantation.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Coronary Intervention | Experimental | Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic and diastolic function
Echocardiographic imaging at short intervals of 10 sec during ischemia, which will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec.
Measured: during 60 seconds ischemia caused by PCI
Secondary outcomes (1)
systolic and diastolic function
Echocardiographic imaging of layer specific systolic and diastolic function at intervals of 20 sec during reperfusion up to 10 min after reopening of the vessel as well 1 hour and 24 hours after percutaneous coronary intervention.
Measured: during 10 minutes, after 1 hour and after 24 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Biomedical Engineering, Technion, Haifa, Israel
- Responsible party
- Sponsor
- Investigators
- Rainer Hoffmann, Prof.Dr., Principal investigator, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004483
- Sponsor's protocol ID
- 10-091
- Other IDs
- 032/10
- Acronym
- PCI-Strain
- Status last verified
- Sep 2015
- First submitted
- 11 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02004483
- Acronym / sponsor ID
- PCI-Strain / 10-091
- Keywords
- percutaneous coronary intervention, ischemia, strain, coronary stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Department of Biomedical Engineering, Technion, Haifa, Israel
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2013 (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.
Investigators will analyzed systolic and diastolic function during and after ischemia induced by percutaneous coronary intervention.Also will be analyzed a local work index during acute ischemia induced by percutaneous coronary intervention.
Detailed description
PART 1: ANALYSIS OF LAYER SPECIFIC SYSTOLIC AND DIASTOLIC FUNCTION DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION 35 patients with normal systolic left ventricular function at baseline with indication for elective percutaneous coronary angioplasty will be included in the study. In these patients acute ischemia will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec. During these 60 seconds ischemia will develop throughout all layers of the myocardium affecting diastolic systolic and diastolic function. During the subsequent reperfusion period signs of ischemia with systolic and diastolic dysfunction of all layers will subside. Echocardiographic imaging at short intervals of 10 sec during ischemia and at intervals of 20 sec during reperfusion up to 10 min after reopening of the vessel as well as 1 hour and 24 hours later will allow serial comparison of strain curves and thereby allow definition of the time sequence systolic and diastolic function abnormalities occur in three myocardial layers as well as the resolution of abnormalities during reperfusion. The analysis of circumferential as well as radial strain will allow definition of differences between radial and circumferential strain during ischemia induction and resolution.
PART 2: ANALYSIS OF LOCAL WORK INDEX DURING ACUTE ISCHEMIA INDUCED BY PERCUTANEOUS CORONARY INTERVENTION.
In the same 35 patients as in Clinical step 1 the local work index of the ischemic area as well as the contralateral non-ischemic areas will be determined in serial studies to determine the onset of abnormality, the amount of abnormality and the resolution of abnormality. Changes in local work index in the ischemic area will be related to changes in peak systolic strain and strain imaging diastolic index.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Coronary Intervention | Experimental | Procedure: Percutaneous Coronary InterventionEach patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Adequate quality of echocardiographic images.
- Significant stenosis of the proximal left anterior descending artery, the right coronary artery or the left circumflex artery
- Anginal pain or proven myocardial ischemia due to the coronary stenosis
- Elective percutaneous coronary intervention planned
Key exclusion criteria (13 listed)
- Prior myocardial infarction
- Significant coronary collaterals
- Significant valvular regurgitation (>Sellers II)
- Congestive heart failure
- Pacemaker dependency
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 |
|---|---|---|
| Percutaneous Coronary InterventionPercutaneous coronary intervention is performed according to standard practice. Direct stenting is required for the procedure as it is done in most coronary interventions today. After insertion of the non-inflated stent into the coronary lesion there should still be flow to the distal vessel. The stent should be implanted at high-pressure with balloon inflation lasting for 60 seconds to allow adequate expansion of the stent. Post-dilatation should be performed if required. However, this should be done more than 5 minutes after stent implantation. | Procedure or surgery | Percutaneous Coronary Intervention |
Primary outcome
systolic and diastolic function
Time frame: during 60 seconds ischemia caused by PCI
Echocardiographic imaging at short intervals of 10 sec during ischemia, which will be induced by elective percutaneous coronary angioplasty with balloon inflation and thus vessel occlusion for 60 sec.
1 secondary outcome
systolic and diastolic function
Time frame: during 10 minutes, after 1 hour and after 24 hours after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Rainer Hoffmann, Prof.Dr. principal investigator
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Percutaneous Coronary Intervention and Myocardial Ischemia, run by RWTH Aachen University 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 23 Sep 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
systolic and diastolic function (time frame: during 60 seconds ischemia caused by PCI). 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 23 Sep 2015.