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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Percutaneous Coronary Intervention; Anginal Pain
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during 60 seconds ischemia caused by PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during 10 minutes, after 1 hour and after 24 hours after PCI

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: Department of Biomedical Engineering, Technion, Haifa, Israel
• Investigators: Principal Investigator: Rainer Hoffmann, Prof.Dr., RWTH Aachen University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; ischemia; strain; coronary stenosis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 10-091; 032/10 (Other Identifier: Ethics)