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

Myocardial Ischemia Clinical Trial

— PCI-Strain  

Official title:

Comprehensive Analysis of Myocardial Layer Specific Systolic and Diastolic Function in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004483
• Other study ID #: 10-091
• Secondary ID: 032/10
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: September 22, 2015
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anginal Pain
• Coronary Artery Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Department of Biomedical Engineering, Technion, Haifa, Israel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes