May 1, 2001CirculationOpen Access

Randomized, Single-Blind, Placebo-Controlled Pilot Study of Catheter-Based Myocardial Gene Transfer for Therapeutic Angiogenesis Using Left Ventricular Electromechanical Mapping in Patients With Chronic Myocardial Ischemia

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Why the study?

Does catheter-based myocardial gene transfer of phVEGF-2 improve safety, symptoms, and myocardial perfusion in patients with chronic myocardial ischemia?

Population

n=6 patients with chronic myocardial ischemia

Comparison

Catheter-based myocardial gene transfer of naked… vs Placebo (mock procedure)

Design

RCT, 1:1, Single-blind, placebo-controlled

Follow-up

up to 360 days

Authors

PVPeter R. ValeInterventional / Structural Cardiology DLDouglas W. LosordoInterventional Cardiology CMCharles E. MillikenSavannah River National Laboratory

Discussion

Member takes

Implication

Supports gene therapy for refractory ischemia; extends preclinical VEGF data to clinical RCT evidence.

Structured PICO

Does catheter-based myocardial gene transfer of phVEGF-2 improve safety, symptoms, and myocardial perfusion in patients with chronic myocardial ischemia?

Population

n=6 patients with chronic myocardial ischemia

Intervention

Catheter-based myocardial gene transfer of naked plasmid DNA encoding vascular endothelial growth factor-2 (phVEGF-2) (total dose, 200 microgram), administered as 6 injections into ischemic myocardium (total, 6.0 mL) guided by NOGA left ventricular electromechanical mapping

Comparator

Placebo (mock procedure)

Outcome

Feasibility and safety (changes in heart rate or blood pressure, sustained ventricular arrhythmias, ECG evidence of infarction, or ventricular perforations)safety

Catheter-based myocardial gene transfer of phVEGF-2 is feasible and safe, with preliminary evidence of reduced ischemia and angina in patients with chronic myocardial ischemia.

Cite This Study

Vale et al. (2001) studied this question.

synapsesocial.com/papers/69fea82dc28c7d12f5f0ca23 https://doi.org/10.1161/01.cir.103.17.2138

Topics

Women and heart disease

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Randomized, Single-Blind, Placebo-Controlled Pilot Study of Catheter-Based Myocardial Gene Transfer for Therapeutic Angiogenesis Using Left Ventricular Electromechanical Mapping in Patients With Chronic Myocardial Ischemia

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Topics

Randomized, Single-Blind, Placebo-Controlled Pilot Study of Catheter-Based Myocardial Gene Transfer for Therapeutic Angiogenesis Using Left Ventricular Electromechanical Mapping in Patients With Chronic Myocardial Ischemia

Discussion

Member takes

Implication

Structured PICO

Cite This Study

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