Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI (REPAIR-ACS)

Johann Wolfgang Goethe University Hospital

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Coronary Artery Disease

Acute Myocardial Infarction

Treatments

Biological: placebo medium

Biological: autologous bone marrow-derived progenitor cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00711542

2007-08-16 REPAIR-ACS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

31 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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