Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-12-31

Brief Summary

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Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor prognosis in patients after acute myocardial infarction.

After acute myocardial infarction, coronary flow reserve remains significantly reduced. A previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete normalization of coronary flow reserve after intracoronary application of autologous bone marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST segment elevation myocardial infarction. The current study is planned to extend these findings to patients with Non-ST segment elevation myocardial infarction, since these patients have an equally reduced outcome.

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Detailed Description

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Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be assessed histological in patients, measurement of coronary flow reserve is an exact means for estimating capillary density and assessing coronary microvascular function. With the help of an intracoronary Doppler Wire, coronary hemodynamics can be assessed at baseline and, for example, adenosin-induced maximal vasodilation. Calculation of the minimal vascular resistance indices allows to estimate the cross-sectional area, reflecting capillary density, and, in comparison with the time of the acute myocardial infarction, estimation of improved neovascularization at a later timepoint.

In order to improve neovascularization, which may then be associated with improved left ventricular contractility, we initiated the current trial.

Conditions

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Coronary Artery Disease Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI

Group Type ACTIVE_COMPARATOR

autologous bone marrow-derived progenitor cells

Intervention Type BIOLOGICAL

intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate

2

Intracoronary infusion of Placebo after NSTEMI

Group Type PLACEBO_COMPARATOR

placebo medium

Intervention Type BIOLOGICAL

intracoronary infusion of placebo medium

Interventions

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autologous bone marrow-derived progenitor cells

intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate

Intervention Type BIOLOGICAL

placebo medium

intracoronary infusion of placebo medium

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Patients with acute coronary syndrome (ST-depression in at least 2 leads \> 0,1 mV), or T-wave inversion, with or without elevated myocardial biomarkers (Troponin T oder I), together with typical clinical presentation), treated as follows:

* Acute percutaneous revascularization with stent implantation within 48 hours after symptom onset.
* Successful acute PCI (residual stenosis \< 30%, TIMI flow \> 2).
* Hemodynamic stability
* Age 18 - 80 years
* Written informed consent
* Active contraception in women of childbearing age

Exclusion Criteria

* Patients with STEMI (ST elevation in 2 leads above 0,2 mV in lead V1, V2 oder V3 or above 0,1 mV in the other leads)
* Necessity of additional PCI in non-infarct vessel at the time of study therapy (multi-vessel PCI in the acute event is possible)
* Heart failure (LVEF ≤ 30 %).
* Arteriovenous malformation or aneurysms
* Active infection (C-reactive protein \> 10 mg/dl), or fever, or diarrhoea within the last 4 weeks
* Chronic inflammatory disease
* HIV infection or active hepatitis
* Neoplastic disease without documented complete remission within the last 5 years
* Recent stroke within the last 3 months
* Impaired kidney function (creatinin \> 2,5 mg/dl) at the time of treatment
* Significant liver disease (GOT \> 2x upper normal value or spontaneous INR \> 1,5.
* Hematopoetic disease (anaemia with Hb\< 8.5 mg/dl; thrombocytopenia \< 100.000/µl; splenomegaly
* Known allergies to Clopidogrel, Heparin or Abciximab
* History of bleeding disorder
* GI bleeding within the last 3 months
* Major surgery or trauma within the last 2 months
* Uncontrolled hypertension
* Pregnancy
* Mental disability
* Previous progenitor cell therapy
* Participation in a different clinical trial within the last 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No