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

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ClinicalTrials.gov Identifier: NCT02004483
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Department of Biomedical Engineering, Technion, Haifa, Israel
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Myocardial Ischemia Anginal Pain Procedure: Percutaneous Coronary Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Study Start Date : August 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Percutaneous Coronary Intervention
Each patient will get elective percutaneous coronary angioplasty with balloon inflation(PCI). During and after PCI 2D-echography (strain) will be performed.
Procedure: Percutaneous Coronary Intervention
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. systolic and diastolic function [ Time Frame: during 10 minutes, after 1 hour and after 24 hours after PCI ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004483


Locations
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Germany
University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Department of Biomedical Engineering, Technion, Haifa, Israel
Investigators
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Principal Investigator: Rainer Hoffmann, Prof.Dr. RWTH Aachen University Hospital

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02004483     History of Changes
Other Study ID Numbers: 10-091
032/10 ( Other Identifier: Ethics )
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
percutaneous coronary intervention
ischemia
strain
coronary stenosis

Additional relevant MeSH terms:
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Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases