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Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI (PCI-Strain)

Primary Purpose

Percutaneous Coronary Intervention, Myocardial Ischemia, Anginal Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Percutaneous Coronary Intervention focused on measuring percutaneous coronary intervention, ischemia, strain, coronary stenosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior myocardial infarction
  • Significant coronary collaterals
  • Significant valvular regurgitation (>Sellers II)
  • Congestive heart failure
  • Pacemaker dependency
  • Bundle branch block or significant arrhythmia
  • 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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Percutaneous Coronary Intervention

Arm Description

Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2013
Last Updated
September 22, 2015
Sponsor
RWTH Aachen University
Collaborators
Department of Biomedical Engineering, Technion, Haifa, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02004483
Brief Title
Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI
Acronym
PCI-Strain
Official Title
Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
Department of Biomedical Engineering, Technion, Haifa, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention, Myocardial Ischemia, Anginal Pain
Keywords
percutaneous coronary intervention, ischemia, strain, coronary stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Coronary Intervention
Arm Type
Experimental
Arm Description
Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
systolic and diastolic function
Description
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.
Time Frame
during 60 seconds ischemia caused by PCI
Secondary Outcome Measure Information:
Title
systolic and diastolic function
Description
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.
Time Frame
during 10 minutes, after 1 hour and after 24 hours after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Prior myocardial infarction Significant coronary collaterals Significant valvular regurgitation (>Sellers II) Congestive heart failure Pacemaker dependency Bundle branch block or significant arrhythmia 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Hoffmann, Prof.Dr.
Organizational Affiliation
RWTH Aachen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI

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